EP1653883A1 - Stent for implantation in a blood vessel, especially in the region of the aortic arch - Google Patents

Stent for implantation in a blood vessel, especially in the region of the aortic arch

Info

Publication number
EP1653883A1
EP1653883A1 EP04763937A EP04763937A EP1653883A1 EP 1653883 A1 EP1653883 A1 EP 1653883A1 EP 04763937 A EP04763937 A EP 04763937A EP 04763937 A EP04763937 A EP 04763937A EP 1653883 A1 EP1653883 A1 EP 1653883A1
Authority
EP
European Patent Office
Prior art keywords
ring
stent
stent according
penultimate
proximal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP04763937A
Other languages
German (de)
French (fr)
Other versions
EP1653883B1 (en
Inventor
Ralf Kaufmann
Rainer Lesmeister
Hardy MÜLLER
Michael Braun
John Geis
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Jotec GmbH
Original Assignee
Jotec GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Jotec GmbH filed Critical Jotec GmbH
Publication of EP1653883A1 publication Critical patent/EP1653883A1/en
Application granted granted Critical
Publication of EP1653883B1 publication Critical patent/EP1653883B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/856Single tubular stent with a side portal passage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/061Blood vessels provided with means for allowing access to secondary lumens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • A61F2002/075Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/828Means for connecting a plurality of stents allowing flexibility of the whole structure

Definitions

  • Stent for implantation in a blood vessel especially in the area of the aortic arch
  • the present invention relates to a stent for implantation in a blood vessel, in particular in the area of the aortic arch, with rings of meandering circumferential supports arranged one behind the other in the longitudinal direction and a prosthesis material fastened to and connecting these rings, which has a hollow cylindrical body with a circumferentially essentially closed jacket forms.
  • vascular stents also known as endovascular stents
  • endovascular stents are implanted in the arteries for the treatment of aneurysms.
  • An aneurysm is understood to mean an expansion or drainage of an arterial blood vessel as a result of congenital or acquired wall changes.
  • the bagging can cover the vessel wall as a whole or, in the case of a so-called false aneurysm, blood can pass from the lumen of the vessel between the vessel wall layers and shear them apart. Failure to treat an aneurysm in advanced stages can lead to rupture of the artery, causing the patient to bleed internally.
  • an aneurysm can also occur in the area of the ascending or descending branch of the aorta (ascending aorta and descending aorta).
  • the ascending branch of the aorta is directly connected to the heart. Starting from the aortic root (sinus aortae), the ascending branch runs upwards in a slightly curved shape from the heart and merges into the aortic arch (arcus aortae).
  • the head vessels branch off, e.g. the left and right carotid arteries.
  • the aortic arch has a curve of approximately 180 ° with a very narrow radius and connects the ascending branch of the aorta with the descending branch.
  • a stent for implantation in the ascending branch of the aorta is known from DE 100 65 824 AI.
  • the known stent has a hollow, hollow-cylindrical body which is open in the longitudinal direction for the passage of blood and has a wall which is formed by a mesh structure.
  • the body of the known Stents are adapted to the anatomical shape of the aortic root and have a concave shape.
  • narrow fixing elements are arranged distributed around the stent in the circumferential direction.
  • the body of the known stent is cut off obliquely, so to speak, so that the stent has a greater length extension on its peripheral region, which in the implanted state is remote from the head vessels, than at the opposite peripheral region. In this way it is avoided that the head vessels branching from the aortic arch are covered by the stent.
  • the known stent has proven to be suitable for use in the area of the ascending aorta, but because of the completely different anatomical relationships in the area of the descending aorta, such a stent cannot be used to treat aneurysms in the area of the descending aorta.
  • a vascular endoprosthesis that is, a corresponding stent.
  • a vascular surgical connection between the proximal of the subclavian sinus artery and the aortic against the outgoing common carotid artery and the subclavian sinus artery, so that the subclavian artery is supplied through the common carotid artery.
  • the exit of the clavicle artery from the aortic arch can then easily be covered by a vascular endoprosthesis and closed by this in order to ensure a sufficient fixation and sealing surface on the aortic inner wall.
  • Vascular surgery of this type is very time-consuming, the patient must also be connected to a heart-lung machine and the patient's body temperature must be cooled down considerably. For this reason, the mortality rate for such interventions is very high.
  • the object of the present invention is to create a stent of the type mentioned at the beginning, which can be placed with its proximal end in the region of the aortic arch.
  • this object is achieved in that at least one connecting support is provided between the last and the penultimate ring at the proximal end of the stent, which connects these two rings to one another.
  • the object underlying the invention is completely achieved in this way.
  • stents with a jacket made of prosthesis material are suitable for implantation into the A. descencens if only a connecting support is provided between the last and the penultimate ring, which connects these two rings to one another.
  • the distal end of the stent lying in the aortic arch is chamfered and, if necessary, open-meshed to ensure that the arteries in the head are supplied.
  • Such a mesh stent is not suitable for the treatment of aneurysms in the area of the descending aorta, although a pure bevel at the proximal end of the stent lying in the aortic arch enables the outgoing arteries to be supplied, but not sufficient fixation.
  • the connecting support now makes it possible, for example, to cut out part of the lateral surface between the last and the penultimate ring or to provide the jacket with holes, so that the supply to the outgoing head arteries is ensured.
  • both the last ring and the connection supports ensure that the proximal end of the new stent is securely fixed in the aortic arch.
  • connection support a covering region that is essentially free of prosthesis material is stretched, the connection support preferably being V-shaped and more preferably that essentially of The prosthesis-free jacket area widens in a wedge shape towards the proximal end of the stent.
  • the advantage here is that, on the one hand, the entire jacket area between the last and the penultimate ring is not formed without prosthesis material.
  • This makes it possible to provide prosthesis material on the inner wall of the aortic arch, which is remote from the outlets of the head arteries, and thus a jacket region which is used not only for support but also as a sealing surface.
  • the V-shaped design of the connection support makes it particularly easy to implement the sheath region that widens in a wedge shape toward the proximal end of the stent and is free of prosthesis material.
  • the jacket is removed in the area of the wedge-shaped jacket area, the resulting edges of the prosthesis material being fastened to the V-shaped struts of the connecting support.
  • the connection between the last and the penultimate ring is also made on the one hand via the jacket, but on the other hand also via the connecting support.
  • the connecting support ensures that the last ring at the proximal end is securely connected to the remaining hollow cylindrical body of the stent, despite the partially removed jacket.
  • the supports have a Z-shaped course with pointed arches alternatingly pointing to the proximal and distal ends of the stent, which are oblique to the Longitudinal support sections are connected to each other.
  • a stent structure is created which exerts sufficient radial pressure to anchor itself in the vascular regions located proximal and distal to the aneurysm, while the stent can withstand the pressure from the blood flowing through it.
  • proximal pointed arches of the last ring are at a distance from the proximal pointed arches of the penultimate ring that is greater than the distance between the proximal pointed arches of the penultimate ring and the proximal pointed arches of the penultimate ring.
  • the last ring is at a greater distance from the penultimate ring than the other rings in the stent among one another.
  • the stent can more easily adapt to the curvature in the aortic arch at its proximal end.
  • this is already made possible by the jacket region, which is essentially free of prosthesis material, but due to the greater distance between the rings at the proximal end, the stiffness is determined more strongly by the remaining prosthesis material than in the other area of the stent, which enables better flexibility.
  • proximal pointed arches of the last ring are at a distance from the distal pointed arches of the penultimate ring which is greater than the distance between see the exit of the subclavian sinistra artery and the exit of the common carotid artery from the aortic arch.
  • This measure has the advantage that the proximal pointed arches of the last ring can lie proximally from the common carotid artery to the inner wall of the aortic arch, while the distal pointed arches of the penultimate ring lie against the inside of the aortic wall distal from the subclavian sinus artery , On the one hand, this ensures that the proximal end of the new stent is securely anchored in the aortic arch, while at the same time preventing excessive pressure being exerted on the inner wall of the aortic area in the area of the branches from the common carotid artery and subclavian artery. Furthermore, this construction makes it possible to choose the sheath region that is essentially free of prosthesis material so that the branches of the common carotid artery and subclavian artery are not covered by prosthesis material.
  • a pointed arch of the penultimate ring facing the distal end of the stent is in contact with a pointed arch of a connecting support, the pointed arch of the penultimate ring facing the distal end of the stent preferably being formed at least partially by the pointed arch of the connecting support.
  • connection support fits into the usual structure of the ring.
  • the distal pointed arch of the penultimate ring can be partially omitted, the resultant gap is filled by the pointed arch of the connection support.
  • connection support has two legs, each of which is in contact with a support section of the last ring at its proximal end.
  • the advantage here is that the Z-shaped course of the last ring does not have to be changed by the connection with the connection support.
  • connection support has two legs, each of which is in contact with a support section of the penultimate ring at its distal end.
  • Another advantage is that due to this structure, pressure on the last ring causes the V-shaped connection support to expand outwards, so that the prosthetic material attached there is pressed outwards against the inner wall of the aortic area, thus sealing the blood flow against it forms the aneurysm volume.
  • the area of the support of the proximal last ring which is not covered by prosthesis material thus bends the proximal end of the prosthesis covered by prosthesis material along the toroidal aortic inner wall and at the same time spreads the wedge-shaped uncovered area with respect to the supra-aortic vascular outlets and presses on the legs of the connection support for sealing the blood flow against the aneurysm volume.
  • the number of pointed arches of the last ring can be equal to that of the penultimate ring.
  • the number of pointed arches of the last ring is less than the number of pointed arches of the penultimate ring.
  • the stent or the distribution of the pointed arches in the last ring of the stent, can be designed, for example, in such a way that there is no free distal pointed arch in the sheath region which is essentially free of prosthesis material and which is spanned in the area of the connection support. As a result, in this embodiment, the stent cannot get caught in the vessel walls when it is withdrawn in the distal direction.
  • This embodiment can also be designed, for example, in such a way that no distal pointed arch is formed in the last ring at that point which corresponds to the pointed arch of the penultimate ring pointing towards the distal end of the stent, which is at least partially formed by the pointed arch of the connecting support. opposite.
  • connection supports are provided, each of which is in contact with a support section of the last ring with its proximal end and with a support section of the penultimate ring in each case with its distal end.
  • the two further connection supports intersect at one point.
  • flank stability and flank tightness can advantageously be increased by the further connecting supports of these embodiments.
  • last ring and the connection support are integrally formed with one another.
  • This measure is structurally advantageous, it is only necessary to bend a conventional Z-shaped ring and then to extend one of the free ends in the direction of the distal region, to deflect it there and to return it to the last ring.
  • this measure is structurally advantageous, because the wire regions lying against one another are crimped to one another in this way.
  • this measure is also Safety aspects of advantage, because in this way the free ends of both the penultimate and the last ring are covered by the crimp sleeves, so that injuries to the aortic inner wall are avoided.
  • pointed arches of the last ring facing the proximal end of the stent are bent outwards relative to the pointed arches facing the distal end of the stent.
  • proximal pointed arches adapt to the inner wall of the aortic arch, which can be regarded as a good approximation as the inner surface of a torus segment.
  • the outward-curved pointed arches create pressure on the aortic wall due to the elasticity of the wire material, which ensures the fixation and positioning as well as the sealing effect of the vascular endoprosthesis, i.e. the stent.
  • the supports and the connecting support consist of a wire-shaped, elastic material.
  • This measure is known per se; it ensures that the stent can first be compressed for insertion into the lumen of the aorta, so that its outer diameter is reduced. After the stent is released, it expands and anchors itself in the corresponding blood vessel.
  • a distal to a distal pointed arch of the connection support on the jacket Marker is attached, wherein a proximal marker is also preferably arranged distal to a support section of the last ring on the jacket, the markers preferably being X-ray markers.
  • This measure has the advantage that a positioning aid is created, by means of which the current position of the stent can be tracked during the implantation and to check the position of the sheath region which is essentially free of prosthesis material compared to the supra-aortic outlets after the implantation.
  • the prosthesis material consists of textile material or of foil, wherein the prosthesis material is further preferably attached to the supports and the connecting support by sewing, gluing or melting.
  • FIG. 1 shows a schematic representation of an embodiment of an endovascular stent implanted in the descending branch of the aorta
  • FIG. 2 shows the support structure for the stent from FIG. 1, but without the surrounding jacket;
  • FIG. 3 shows the proximal last and penultimate ring of the stent from FIG. 2, still without connection to one another;
  • FIG. 5 shows a further embodiment of the stent according to the invention without a surrounding jacket
  • FIG. 6 shows yet another embodiment of the stent according to the invention with additional connection supports, likewise without a surrounding jacket;
  • FIG. 7a shows the proximal last and penultimate ring of the stent from FIG. 6, with the connecting supports to be attached, but still without the connection to one another;
  • FIG. 7b shows the two rings from FIG. 7a, now interconnected by pressing sleeves;
  • FIG. 8 in turn shows a further embodiment of the stent according to the invention with intersecting additional connection supports without a surrounding jacket;
  • FIG. 9a the proximal last and penultimate ring of the stent from FIG. 8, with the connecting supports to be attached and crossing, still without connection to one another;
  • a stent is shown at 10, which is anchored with its proximal end 11 in the aortic arch 12 and with its distal end 14 in the descending aorta 15.
  • the ascending branch 16 (ascending artery) of the aorta is connected to the left ventricle of the heart, also not shown, via the aortic root (sinus aortae), which is not shown in FIG. 1.
  • the ascending aorta 16 is connected to the descending aorta 15 via the aortic arch 12.
  • an aneurysm is shown at 21 in the descending aorta 15, which is, so to speak, bridged by the stent 10.
  • the Blood flow coming from the ascending aorta 16 passes through the aortic arch 12 into the proximal end 11 of the stent 10 and leaves it at the distal end 14.
  • the stent 10 has a hollow cylindrical body 22, which is shown schematically in FIG indicated rings 23 is formed from meandering supports 24 which are connected to each other by prosthesis material 25.
  • the prosthesis material 25 is a textile material or a film in a known manner and is fastened to the supports 24 by sewing, gluing or melting.
  • the stent 10 At its proximal end 11, the stent 10 has a wedge-shaped, free sheath region 27 that widens toward the proximal end 11 and is stretched between a proximal last ring 28, a proximal penultimate ring 29 and a connecting support 31 that also supports the last ring 28 connects the penultimate ring 29.
  • This mantle region 27, which is essentially free of prosthesis material 25, makes it possible for blood brought from the ascending aorta 16 to reach the common carotid artery 18 and the subclavian sinus artery 19. Outside the free sheath area 27, however, there is prosthesis material 25 between the last ring 28 and the penultimate ring 29, so that the stent 10 here clings closely to the aortic inner wall indicated at 30 with its proximal end. This prevents blood from passing between the stent 10 and the aortic inner wall 30 into the region of the aneurysm. mas 21 succeeded, possibly expanding it further and finally leading to rupture.
  • the structural design of the stent 10 from FIG. 1 is shown in more detail in the schematic side view of FIG. 2, the prosthesis material 25 being omitted in FIG. 2 for reasons of clarity.
  • the last ring 28, the penultimate ring 29 and further rings 23 are arranged one behind the other in the longitudinal direction 32, only one of which is shown.
  • Each of these rings 23, 28, 29 has a plurality of proximal pointed arches 33 and distal pointed arches 34 which are connected to one another by support sections 35 which run obliquely to the longitudinal direction 32.
  • the rings 23, 28 and 29 consisting of meandering circumferential supports 24 are formed.
  • both the supports 24 and the connecting support 31 consist of a wire-shaped, elastic material.
  • the proximal pointed arches 33 of the last ring 28 are at a distance from the proximal pointed arches 33 of the penultimate ring 29 which is greater than the distance 37 between the proximal pointed arches 33 of the penultimate ring 29 and the proximal pointed arches 33 of the penultimate ring 23 In this way, the stent 10 is more flexible and movable at its proximal end 11 than in the direction of its distal end 14.
  • the proximal pointed arches 33 of the last ring 28 face the distal pointed arches 34 of the penultimate ring 29 Distance 38, which is greater than the distance 39 indicated in FIG. 1 between the exit of the subclavian artery sinistra 19 and the exit of the common carotid artery 18 from the aortic arch 12.
  • the proximal last ring 28 can be located proximally from the artery Carotis communis clamp against the aortic inner wall 30, while the penultimate ring 29 clamp distally to the subclavian sinus artery and there the prosthesis material 25 can press against the inner circumference of the aortic wall 30.
  • the V-shaped connecting support 31 which connects the last ring 28 and the penultimate ring 29 to one another, has a distal pointed arch 41 and two legs 42 adjoining the pointed arch 41, which extend in a V-shape to the distal end 11 of the stent 10 ,
  • the legs 42 have their proximal ends 43 in contact with support sections 35 of the last ring 28. With their distal ends 44, the legs 42 are in contact with corresponding support sections 35 of the penultimate ring 29.
  • the connection between the support sections 35 and the respective ends 43 , 44 of the leg 42 takes place via pressing sleeves 45, which also close the meandering supports 24, for example of the ring 23, to their Z-shaped course.
  • Fig. 3 the last ring 28 and the penultimate ring 29 are shown immediately after manufacture, that is, before the connection with each other.
  • the last ring 28 is formed starting at its free end 49 by multiple Z-shaped bending of the corresponding wire material, so that the proximal and distal arches 33 and 34 are formed.
  • the wire material is advanced distally and bent at the distal arch 41 and returned to the support section 35 where the wire is cut off to give the second free end 50 of the one-piece structure which is both the last ring 28 and also represents the connection support 31.
  • the penultimate ring 29 accordingly has two free ends 51 and 52, which are located on both sides of the gap 48.
  • the last ring 28 and the penultimate ring 29 together with the connection support 31 form a fixation structure which is provided at the proximal end 11 of the stent 10.
  • the inner wall of the aorta opposite and proximal to the outlet of the subclavian artery can also be used as a fixation and sealing surface without this outlet being closed. If the new stent in it for that implanted area, it is no longer necessary to carry out a stressful service intervention beforehand.
  • the proximal pointed arches 33 of the last ring 28 are widened or bent outwards relative to the distal pointed arches 34, which can be seen in FIG. 2 at the top.
  • the pointed arches 33 adapt to the aortic inner wall 30 and at the same time generate pressure on the inner aortic wall 30 due to the elasticity of the wire material, which ensures the fixation and positioning as well as the sealing effect of the vascular endoprosthesis.
  • the last ring 28 can be bent forward, as a result of which the legs 42 of the connecting support 31 spread outward and fit closely against the aortic inner wall 30. This is further supported by the pressure exerted by the inner wall of the aortic on the last ring 28, which also expands the legs 42 of the connecting support 31 to the outside under pressure. In this way, the prosthesis material fastened there is pressed outward against the aortic inner wall 30 and thus forms a seal of the blood flow against the volume of the aneurysm 21.
  • the area 27 remaining free from the prosthesis material 25 ensures the appropriate supply of the subclavian sinus artery 19 and the common carotid artery 18.
  • the marker 46 is a distal marker, which is arranged distral to the distal pointed arch 41 of the connecting support 31.
  • the marker 47 is a proximal marker that is attached distally to a support section of the last ring 28 on the jacket 26.
  • FIG. 5 A further embodiment of the stent according to the invention is shown in a schematic side view in FIG. 5, the prosthesis material 25 also being omitted here, as in FIG. 2, for reasons of clarity. 5 to 9a, the same reference numerals as in Fig. 2 have been used to designate the same elements of the stents.
  • the last ring 28 has a proximal pointed arch 33 - and thus also a distal pointed arch 34 - less than the penultimate ring 29 and than the ring 23. In this embodiment, the distal one is therefore missing in comparison to FIG. 2 Ogive 39 (see Fig. 2).
  • FIG. 6 shows a further embodiment of the stent according to the invention, this embodiment having additional connection supports 61 and 62 in comparison to the embodiment from FIG. 2.
  • the connecting supports 61 and 62 are each with their proximal end 63 with a support section 35 of the last ring 28 and with their distal end 64 each with a support section 35 of the penultimate ring 29 in Plant brought. It can be seen in FIG. 6 that the additional connection supports 61 and 62 thereby represent a type of flank reinforcement for the stent.
  • Fig. 7a the last ring 28 and the penultimate ring 29 are shown immediately after manufacture, that is, before they are connected to one another. 7a - as in FIG. 3 - it can be seen that the last ring 28 and the connecting support 31 are formed in one piece with one another.
  • the additional connecting supports 61 and 62 are brought into contact with their proximal end 63 with a support section 35 of the last ring 28, which is indicated by the arrows 65, and the distal ends 64 each with a support section 35 of the penultimate ring 29, which is indicated by the Arrows 66 is indicated.
  • FIG. 7b it can be seen that the two rings 28 and 29 are brought together, the ends each being connected to the corresponding support sections 35 via press sleeves 68, so that injuries to the aortic inner wall are avoided.
  • FIG. 8 A further embodiment of the stent according to the invention is shown in FIG. 8, two additional connection supports 71 and 72 also being provided here as in FIG. 6, but which intersect at a point 77.

Abstract

A stent (10) for implantation in a blood vessel (15), especially in the region of the aortic arch (12), comprising rings (23, 28, 29) which are disposed successively in the longitudinal direction thereof and which are made of meander-shaped peripheral supports (24) and a prosthesis material (25) which is fixed to the rings (23, 28, 29) and which connects them, said material forming a hollow cylindrical body (22) with a jacket (26) which is substantially closed on the periphery thereof. At least one connecting support (31; 61, 62; 71, 72) is provided between the last ring (28) and the penultimate ring (29) on the proximal send (11) of the stent (10). Said connecting support connects the two rings (28,29) to each other.

Description

Stent zur Implantation in ein Blutgefäß, insbesondere im Bereich des Aortenbogens Stent for implantation in a blood vessel, especially in the area of the aortic arch
Die vorliegende Erfindung betrifft einen Stent zur Implantation in ein Blutgefäß, insbesondere im Bereich des Aortenbogens, mit in seiner Längsrichtung hintereinander angeordneten Ringen aus mäanderförmig umlaufenden Stützen und einem an den Ringen befestigten und diese verbindenden Prothesenmaterial, das einen hohlzylindrischen Körper mit umfänglich im Wesentlichen geschlossenen Mantel bildet.The present invention relates to a stent for implantation in a blood vessel, in particular in the area of the aortic arch, with rings of meandering circumferential supports arranged one behind the other in the longitudinal direction and a prosthesis material fastened to and connecting these rings, which has a hollow cylindrical body with a circumferentially essentially closed jacket forms.
Ein derartiger Stent, allerdings nicht zur Implantation in den Aortenbogen, ist aus dem Stand der Technik bekannt. Such a stent, but not for implantation in the aortic arch, is known from the prior art.
Diese auch als endovaskuläre Stents bezeichneten Gefäßstents werden zur Behandlung von Aneurysmen in Arterien implantiert. Unter einem Aneurysma versteht man eine Ausweitung oder Aussa- ckung eines arteriellen Blutgefäßes infolge angeborener oder erworbener Wandveränderungen. Die Aussackung kann dabei die Gefäßwand als Ganzes erfassen oder es kann bei einem sog. falschen Aneurysma Blut aus dem Lumen des Gefäßes zwischen die Gefäßwandschichten treten und diese auseinander scheren. Die Nichtbehandlung eines Aneurysma kann im fortgeschrittenen Stadium zu einer Ruptur der Arterie führen, woraufhin der Patient innerlich verbluten kann.These vascular stents, also known as endovascular stents, are implanted in the arteries for the treatment of aneurysms. An aneurysm is understood to mean an expansion or drainage of an arterial blood vessel as a result of congenital or acquired wall changes. The bagging can cover the vessel wall as a whole or, in the case of a so-called false aneurysm, blood can pass from the lumen of the vessel between the vessel wall layers and shear them apart. Failure to treat an aneurysm in advanced stages can lead to rupture of the artery, causing the patient to bleed internally.
Aneurysmen treten zwar häufig im Bereich der Baucharterie (Aorta abdominalis) oder Brustarterie (Aorta thoracica) auf, ein Aneurysma kann aber auch im Bereich des aufsteigenden oder absteigenden Astes der Aorta (Aorta ascendens und Aorta descen- dens) auftreten. Der aufsteigende Ast der Aorta ist unmittelbar mit dem Herzen verbunden. Ausgehend von der Aortenwurzel (Sinus aortae) verläuft der aufsteigende Ast in leicht gekrümmter Form vom Herzen weg nach oben und geht dort in den Aortenbogen (Ar- cus aortae) über. Im Bereich des Aortenbogens zweigen die Kopfgefäße ab, u.a. die linke und die rechte Halsschlagader. Der Aortenbogen weist einen Kurvenverlauf von etwa 180° mit einem sehr engen Radius auf und verbindet den aufsteigenden Ast der Aorta mit dem absteigenden Ast.Although aneurysms often occur in the abdominal artery (abdominal aorta) or thoracic artery (thoracic aorta), an aneurysm can also occur in the area of the ascending or descending branch of the aorta (ascending aorta and descending aorta). The ascending branch of the aorta is directly connected to the heart. Starting from the aortic root (sinus aortae), the ascending branch runs upwards in a slightly curved shape from the heart and merges into the aortic arch (arcus aortae). In the area of the aortic arch, the head vessels branch off, e.g. the left and right carotid arteries. The aortic arch has a curve of approximately 180 ° with a very narrow radius and connects the ascending branch of the aorta with the descending branch.
Aus der DE 100 65 824 AI ist ein Stent zur Implantation in den aufsteigenden Ast der Aorta bekannt. Der bekannte Stent weist einen hohlen, in Längsrichtung für den Durchgang von Blut offenen, hohlzylindrischen Körper mit einer Wand auf, die durch eine Maschenstruktur gebildet ist. Der Körper des bekannten Stents ist der anatomischen Form der Aortenwurzel angepasst und sich konkav erweiternd ausgebildet. An seinem dem Herzen zugewandten proximalen Ende sind an dem Stent in Umfangsrichtung verteilt schmale Fixierelemente angeordnet. An seinem in den Aortenbogen hineinreichenden distalen Ende ist der Körper des bekannten Stents sozusagen schräg abgeschnitten, so dass der Stent auf seinem Umfangsbereich, der im implantierten Zustand von den Kopfgefäßen weggelegen ist, eine größere Längenausdehnung aufweist als an dem gegenüberliegenden Umfangbereich. Auf diese Weise wird vermieden, dass die vom Aortenbogen abzweigenden Kopfgefäße durch den Stent abgedeckt werden.A stent for implantation in the ascending branch of the aorta is known from DE 100 65 824 AI. The known stent has a hollow, hollow-cylindrical body which is open in the longitudinal direction for the passage of blood and has a wall which is formed by a mesh structure. The body of the known Stents are adapted to the anatomical shape of the aortic root and have a concave shape. At its proximal end facing the heart, narrow fixing elements are arranged distributed around the stent in the circumferential direction. At its distal end, which extends into the aortic arch, the body of the known stent is cut off obliquely, so to speak, so that the stent has a greater length extension on its peripheral region, which in the implanted state is remote from the head vessels, than at the opposite peripheral region. In this way it is avoided that the head vessels branching from the aortic arch are covered by the stent.
Der bekannte Stent hat sich als im Bereich der Aorta ascendens gut einsetzbar erwiesen, auf Grund der völlig anders gelagerten anatomischen Verhältnisse im Bereich der Aorta descendens kann jedoch ein derart ausgebildeter Stent nicht verwendet werden, um Aneurysmen im Bereich der Aorta descendens zu behandeln.The known stent has proven to be suitable for use in the area of the ascending aorta, but because of the completely different anatomical relationships in the area of the descending aorta, such a stent cannot be used to treat aneurysms in the area of the descending aorta.
Bei derartigen thorakalen Aortenaneurysmen, die sich ggf. bis in den Aortenbogen, also bis zur linken Schlüsselbeinarterie (A. subclavia sinistra) ausdehnen, besteht nämlich das Problem, dass für die Stents nicht genügend proximale Fixierungs- und Dichtungsfläche vorhanden ist. Mit anderen Worten, der bekannte Stent kann im Aortenbogen gegenüber und proximal des Abganges der A. subclavia sinistra nicht hinreichend fixiert werden.The problem with such thoracic aortic aneurysms, which may extend into the aortic arch, i.e. to the left subclavian artery (A. subclavia sinistra), is that there is insufficient proximal fixation and sealing surface for the stents. In other words, the known stent cannot be adequately fixed in the aortic arch opposite and proximal to the outlet of the subclavian sinus artery.
In einem solchen Fall sind deshalb vor der endoluminalen Implantation einer Gefäßendoprothese, also eines entsprechenden Stents, chirurgische Eingriffe erforderlich. Dabei wird vor der Implantation des Stents eine gefäßchirurgische Verbindung zwischen der proximal von der A. subclavia sinistra vom Aortenbo- gen abgehenden A. carotis communis und der A. subclavia sinistra geschaffen, so dass die Schlüsselbeinarterie sozusagen über die A. carotis communis versorgt wird. Der Abgang der Schlüsselbeinarterie vom Aortenbogen kann dann problemlos von einer Gefäßendoprothese überdeckt und durch diese verschlossen werden, um für eine ausreichende Fixierungs- und Dichtungsfläche an der Aorteninnenwand zu sorgen.In such a case, surgical interventions are therefore required before the endoluminal implantation of a vascular endoprosthesis, that is, a corresponding stent. Before the stent is implanted, a vascular surgical connection between the proximal of the subclavian sinus artery and the aortic against the outgoing common carotid artery and the subclavian sinus artery, so that the subclavian artery is supplied through the common carotid artery. The exit of the clavicle artery from the aortic arch can then easily be covered by a vascular endoprosthesis and closed by this in order to ensure a sufficient fixation and sealing surface on the aortic inner wall.
Derartige gefäßchirurgische Eingriffe sind sehr zeitaufwendig, zudem muss der Patient an eine Herz-Lungen-Maschine angeschlossen und die Körpertemperatur des Patienten stark heruntergekühlt werden. Aus diesem Grund liegt die Mortalitätsrate bei derartigen Eingriffen sehr hoch.Vascular surgery of this type is very time-consuming, the patient must also be connected to a heart-lung machine and the patient's body temperature must be cooled down considerably. For this reason, the mortality rate for such interventions is very high.
Ein weiterer Nachteil ist darin zu sehen, dass eine Notversorgung eines Patienten mit thorakalem Aortenaneurysma durch Einführen eines Stents auf minimal-invasivem Wege bisher quasi nicht möglich ist, da eine hinreichend sichere Fixierung des proximalen Endes des Stents Probleme bereitet.Another disadvantage is the fact that emergency care for a patient with a thoracic aortic aneurysm by inserting a stent in a minimally invasive way has hitherto been virtually impossible since a sufficiently secure fixation of the proximal end of the stent causes problems.
Vor diesem Hintergrund liegt der vorliegenden Erfindung die Aufgabe zugrunde, einen Stent der eingangs genannten Art zu schaffen, der mit seinem proximalen Ende im Bereich des Aortenbogens platziert werden kann.Against this background, the object of the present invention is to create a stent of the type mentioned at the beginning, which can be placed with its proximal end in the region of the aortic arch.
Bei dem eingangs genannten Stent wird diese Aufgabe erfindungsgemäß dadurch gelöst, dass zwischen dem letzten und dem vorletzten Ring am proximalen Ende des Stents zumindest eine Verbindungsstütze vorgesehen ist, die diese beiden Ringe miteinander verbindet. Die der Erfindung zugrundeliegende Aufgabe wird auf diese Weise vollkommen gelöst.In the case of the stent mentioned at the outset, this object is achieved in that at least one connecting support is provided between the last and the penultimate ring at the proximal end of the stent, which connects these two rings to one another. The object underlying the invention is completely achieved in this way.
Die Erfinder der vorliegenden Anmeldung haben nämlich erkannt, dass auch Stents mit einem Mantel aus Prothesenmaterial zur Implantation in die A. descencens geeignet sind, wenn nur zwischen dem letzten und dem vorletzten Ring eine Verbindungsstütze vorgesehen, die diese beiden Ringe miteinander verbindet. Bei dem zur Implantation in die A. ascendens geeigneten Stent gemäß DE 100 65 824 ist das im Aortenbogen liegende distale Ende des Stents abgeschrägt und ggf. offenmaschig, um eine Versorgung der Kopfarterien zu gewährleisten. Ein derartiger Maschenstent ist zur Behandlung von Aneurysmen im Bereich der Aorta descendens nicht geeignet, wobei auch eine reine Abschrägung am im Aortenbogen liegenden proximalen Ende des Stents zwar die Versorgung der abgehenden Arterien ermöglicht, nicht jedoch eine hinreichende Fixierung. Die Verbindungsstütze ermöglicht es jetzt dagegen, zwischen dem letzten und dem vorletzten Ring bspw. einen Teil der Mantelfläche auszusparen oder den Mantel mit Löchern zu versehen, so dass die Versorgung der abgehenden Kopfarterien gesichert ist. Andererseits sorgen sowohl der letzte Ring als auch die Verbindungsstützen dafür, dass das proximale Ende des neuen Stents sicher im Aortenbogen fixiert wird.The inventors of the present application have recognized that stents with a jacket made of prosthesis material are suitable for implantation into the A. descencens if only a connecting support is provided between the last and the penultimate ring, which connects these two rings to one another. In the case of the stent suitable for implantation in the ascending artery according to DE 100 65 824, the distal end of the stent lying in the aortic arch is chamfered and, if necessary, open-meshed to ensure that the arteries in the head are supplied. Such a mesh stent is not suitable for the treatment of aneurysms in the area of the descending aorta, although a pure bevel at the proximal end of the stent lying in the aortic arch enables the outgoing arteries to be supplied, but not sufficient fixation. By contrast, the connecting support now makes it possible, for example, to cut out part of the lateral surface between the last and the penultimate ring or to provide the jacket with holes, so that the supply to the outgoing head arteries is ensured. On the other hand, both the last ring and the connection supports ensure that the proximal end of the new stent is securely fixed in the aortic arch.
Dabei ist es bevorzugt, wenn zwischen dem letzten und dem vorletzten Ring im Bereich der Verbindungsstütze ein im Wesentlichen von Prothesenmaterial freier Mantelbereich aufgespannt ist, wobei die Verbindungsstütze vorzugsweise V-förmig ausgebildet ist und weiter vorzugsweise der im Wesentlichen vom Prothesenmaterial freie Mantelbereich sich zum proximalen Ende des Stents keilförmig aufweitet.In this case, it is preferred if between the last and the penultimate ring in the area of the connection support a covering region that is essentially free of prosthesis material is stretched, the connection support preferably being V-shaped and more preferably that essentially of The prosthesis-free jacket area widens in a wedge shape towards the proximal end of the stent.
Hier ist von Vorteil, dass zum einen nicht der gesamte Mantelbereich zwischen dem letzten und dem vorletzten Ring ohne Prothesenmaterial ausgebildet ist. Dadurch ist es möglich, an der von den Abgängen der Kopfarterien abgelegenen Innenwand des Aortenbogens Prothesenmaterial und damit einen Mantelbereich vorzusehen, der nicht nur zur Abstützung, sondern auch als Dichtungsfläche verwendet wird. Durch die V-förmige Ausbildung der Verbindungsstütze lässt sich der sich zum proximalen Ende des Stents keilförmig aufweitende, von Prothesenmaterial freie Mantelbereich besonders einfach realisieren. Der Mantel ist im Bereich des keilförmigen Mantelbereiches entfernt, wobei die sich so ergebenden Kanten des Prothesenmaterials an den V- förmigen Streben der Verbindungsstütze befestigt werden.The advantage here is that, on the one hand, the entire jacket area between the last and the penultimate ring is not formed without prosthesis material. This makes it possible to provide prosthesis material on the inner wall of the aortic arch, which is remote from the outlets of the head arteries, and thus a jacket region which is used not only for support but also as a sealing surface. The V-shaped design of the connection support makes it particularly easy to implement the sheath region that widens in a wedge shape toward the proximal end of the stent and is free of prosthesis material. The jacket is removed in the area of the wedge-shaped jacket area, the resulting edges of the prosthesis material being fastened to the V-shaped struts of the connecting support.
Während im distalen Bereich des neuen Stents die einzelnen Ringe miteinander lediglich über den Mantel, also das Prothesenmaterial, verbunden sind, erfolgt die Verbindung zwischen dem letzten und dem vorletzten Ring zum einen ebenfalls über den Mantel, andererseits aber auch über die Verbindungsstütze. Die Verbindungsstütze sorgt dafür, dass trotz des teilweise entfernten Mantels der letzte Ring am proximalen Ende sicher mit dem restlichen hohlzylindrischen Körper des Stents verbunden ist.While the individual rings in the distal region of the new stent are connected to one another only via the jacket, that is to say the prosthesis material, the connection between the last and the penultimate ring is also made on the one hand via the jacket, but on the other hand also via the connecting support. The connecting support ensures that the last ring at the proximal end is securely connected to the remaining hollow cylindrical body of the stent, despite the partially removed jacket.
Allgemein ist es bevorzugt, wenn die Stützen einen Z-förmigen Verlauf mit abwechselnd zum proximalen und zum distalen Ende des Stents weisenden Spitzbögen aufweisen, die durch schräg zur Längsrichtung verlaufende Stützabschnitte miteinander verbunden sind.In general, it is preferred if the supports have a Z-shaped course with pointed arches alternatingly pointing to the proximal and distal ends of the stent, which are oblique to the Longitudinal support sections are connected to each other.
Auf diese Weise wird eine Stentstruktur geschaffen, die einen hinreichenden radialen Druck ausübt, um sich in den proximal und distal vom Aneurysma liegenden Gefäßbereichen zu verankern, wobei andererseits der Stent dem Druck durch das durch ihn hindurchfließende Blut standhalten kann.In this way, a stent structure is created which exerts sufficient radial pressure to anchor itself in the vascular regions located proximal and distal to the aneurysm, while the stent can withstand the pressure from the blood flowing through it.
Dabei ist es bevorzugt, wenn die proximalen Spitzbögen des letzten Ringes zu den proximalen Spitzbögen des vorletzten Ringes einen Abstand aufweisen, der größer ist als der Abstand zwischen den proximalen Spitzbögen des vorletzten Ringes und den proximalen Spitzbögen des vorvorletzten Ringes .It is preferred if the proximal pointed arches of the last ring are at a distance from the proximal pointed arches of the penultimate ring that is greater than the distance between the proximal pointed arches of the penultimate ring and the proximal pointed arches of the penultimate ring.
Mit anderen Worten, der letzte Ring weist einen größeren Abstand zum vorletzten Ring auf als die anderen Ringe im Stent untereinander .In other words, the last ring is at a greater distance from the penultimate ring than the other rings in the stent among one another.
Dies hat den Vorteil, dass sich der Stent an seinem proximalen Ende leichter der Krümmung im Aortenbogen anpassen kann. Dies wird zwar zum einen bereits durch den im Wesentlichen von Prothesenmaterial freien Mantelbereich ermöglicht, durch den größeren Abstand zwischen den Ringen am proximalen Ende wird hier die Steifigkeit jedoch stärker durch das verbleibende Prothesenmaterial bestimmt als im sonstigen Bereich des Stents, was eine bessere Biegsamkeit ermöglicht.This has the advantage that the stent can more easily adapt to the curvature in the aortic arch at its proximal end. On the one hand, this is already made possible by the jacket region, which is essentially free of prosthesis material, but due to the greater distance between the rings at the proximal end, the stiffness is determined more strongly by the remaining prosthesis material than in the other area of the stent, which enables better flexibility.
Weiter ist es bevorzugt, wenn die proximalen Spitzbögen des letzten Ringes zu den distalen Spitzbögen des vorletzten Ringes einen Abstand aufweisen, der größer ist als der Abstand zwi- sehen dem Abgang der A. subclavia sinistra und dem Abgang der A. carotis communis vom Aortenbogen.It is further preferred if the proximal pointed arches of the last ring are at a distance from the distal pointed arches of the penultimate ring which is greater than the distance between see the exit of the subclavian sinistra artery and the exit of the common carotid artery from the aortic arch.
Bei dieser Maßnahme ist von Vorteil, dass die proximalen Spitzbögen des letzten Ringes sich proximal von der A. carotis communis an die Innenwand des Aortenbogens anlegen können, während die distalen Spitzbögen des vorletzten Ringes sich distal von der A. subclavia sinistra innen an die Aortenwand anlegen. Damit wird zum einen für eine sichere Verankerung des proximalen Endes des neuen Stents im Aortenbogen gesorgt, wobei gleichzeitig verhindert wird, dass im Bereich der Abgänge von A. carotis communis und A. subclavia sinistra ein zu starker Druck auf die Aorteninnenwand ausgeübt wird. Ferner ermöglicht es diese Konstruktion, den im Wesentlichen von Prothesenmaterial freien Mantelbereich so zu wählen, dass die Abgänge von A. carotis communis und A. subclavia sinistra nicht von Prothesenmaterial bedeckt werden.This measure has the advantage that the proximal pointed arches of the last ring can lie proximally from the common carotid artery to the inner wall of the aortic arch, while the distal pointed arches of the penultimate ring lie against the inside of the aortic wall distal from the subclavian sinus artery , On the one hand, this ensures that the proximal end of the new stent is securely anchored in the aortic arch, while at the same time preventing excessive pressure being exerted on the inner wall of the aortic area in the area of the branches from the common carotid artery and subclavian artery. Furthermore, this construction makes it possible to choose the sheath region that is essentially free of prosthesis material so that the branches of the common carotid artery and subclavian artery are not covered by prosthesis material.
Allgemein ist es bevorzugt, wenn ein zum distalen Ende des Stents weisender Spitzbogen des vorletzten Ringes mit einem Spitzbogen einer Verbindungsstütze in Anlage ist, wobei vorzugsweise der zum distalen Ende des Stents weisende Spitzbogen des vorletzten Ringes zumindest teilweise durch den Spitzbogen der Verbindungsstütze gebildet ist.In general, it is preferred if a pointed arch of the penultimate ring facing the distal end of the stent is in contact with a pointed arch of a connecting support, the pointed arch of the penultimate ring facing the distal end of the stent preferably being formed at least partially by the pointed arch of the connecting support.
Hier ist von Vorteil, dass der Z-förmige Verlauf des vorletzten Ringes durch die Verbindungsstütze nicht verändert wird, die Verbindungsstütze passt sich vielmehr in die übliche Struktur des Ringes ein. Dabei kann der distale Spitzbogen des vorletzten Ringes teilweise weggelassen werden, wobei die so entste- hende Lücke durch den Spitzbogen der Verbindungsstütze ausgefüllt ist.The advantage here is that the Z-shaped course of the penultimate ring is not changed by the connection support, rather the connection support fits into the usual structure of the ring. The distal pointed arch of the penultimate ring can be partially omitted, the resultant gap is filled by the pointed arch of the connection support.
Weiter ist es bevorzugt, wenn die Verbindungsstütze zwei Schenkel aufweist, die an ihrem proximalen Ende jeweils mit einem Stützabschnitt des letzten Ringes in Anlage sind.It is further preferred if the connection support has two legs, each of which is in contact with a support section of the last ring at its proximal end.
Hier ist von Vorteil, dass auch der Z-förmige Verlauf des letzten Ringes durch die Verbindung mit der Verbindungsstütze nicht verändert werden muss.The advantage here is that the Z-shaped course of the last ring does not have to be changed by the connection with the connection support.
Dabei ist es weiter bevorzugt, wenn die Verbindungsstütze zwei Schenkel aufweist, die an ihrem distalen Ende jeweils mit einem Stützabschnitt des vorletzten Ringes in Anlage sind.It is further preferred if the connection support has two legs, each of which is in contact with a support section of the penultimate ring at its distal end.
Wie bereits erwähnt, hat diese Maßnahme konstruktive Vorteile, der Z-förmige Verlauf des letzten und vorletzten Ringes wird nicht gestört.As already mentioned, this measure has constructive advantages, the Z-shaped course of the last and penultimate ring is not disturbed.
Ein weiterer Vorteil liegt darin, dass durch diese Struktur ein Druck auf den letzten Ring dazu führt, dass sich die V-förmige Verbindungsstütze nach außen aufspreizt, so dass das dort befestigte Prothesenmaterial nach außen an die Aorteninnenwand gedrückt wird und so eine Abdichtung des Blutstromes gegen das Aneurysmavolumen bildet. Der nicht von Prothesenmaterial bedeckte Bereich der Stütze des proximal letzten Ringes sorgt dabei also für eine Verbiegung des von Prothesenmaterial bedeckten proximalen Prothesenendes entlang der torusförmigen Aorteninnenwand und gleichzeitig für ein Aufspreizen des keilförmigen ungedeckten Bereiches gegenüber den supraaortalen Gefäßabgängen sowie für das Aufdrücken der Schenkel der Verbin- dungsstütze zur Abdichtung des Blutstromes gegen das Aneurysmavolumen.Another advantage is that due to this structure, pressure on the last ring causes the V-shaped connection support to expand outwards, so that the prosthetic material attached there is pressed outwards against the inner wall of the aortic area, thus sealing the blood flow against it forms the aneurysm volume. The area of the support of the proximal last ring which is not covered by prosthesis material thus bends the proximal end of the prosthesis covered by prosthesis material along the toroidal aortic inner wall and at the same time spreads the wedge-shaped uncovered area with respect to the supra-aortic vascular outlets and presses on the legs of the connection support for sealing the blood flow against the aneurysm volume.
Bei den oben stehenden Ausführungsformen des erfindungsgemäßen Stents kann dabei die Anzahl der Spitzbögen des letzten Rings gleich derjenigen des vorletzten Rings sein.In the above embodiments of the stent according to the invention, the number of pointed arches of the last ring can be equal to that of the penultimate ring.
In einer anderen Ausführungsform ist es bevorzugt, wenn die Anzahl der Spitzbögen des letzten Ringes geringer ist als die Anzahl der Spitzbögen des vorletzten Ringes.In another embodiment, it is preferred if the number of pointed arches of the last ring is less than the number of pointed arches of the penultimate ring.
Der Stent, bzw. die Verteilung der Spitzbögen im letzten Ring des Stents, kann dabei bspw. derart ausgebildet sein, dass in dem im Wesentlichen von Prothesenmaterial freien Mantelbereich, der im Bereich der Verbindungsstütze aufgespannt ist, kein freier distaler Spitzbogen vorliegt. Dadurch kann sich der Stent bei dieser Ausführungsform beim Zurückziehen in die distale Richtung nicht in den Gefäßwänden verhaken.The stent, or the distribution of the pointed arches in the last ring of the stent, can be designed, for example, in such a way that there is no free distal pointed arch in the sheath region which is essentially free of prosthesis material and which is spanned in the area of the connection support. As a result, in this embodiment, the stent cannot get caught in the vessel walls when it is withdrawn in the distal direction.
Diese Ausführungsform kann ferner bspw. derart ausgebildet sein, dass im letzten Ring an derjenigen Stelle kein distaler Spitzbogen ausgebildet ist, die dem zum distalen Ende des Stents weisenden Spitzbogen des vorletzten Rings, der zumindest teilweise durch den Spitzbogen der Verbindungsstütze gebildet ist, entspricht bzw. gegenüberliegt.This embodiment can also be designed, for example, in such a way that no distal pointed arch is formed in the last ring at that point which corresponds to the pointed arch of the penultimate ring pointing towards the distal end of the stent, which is at least partially formed by the pointed arch of the connecting support. opposite.
In wiederum einer anderen Ausführungsform ist bevorzugt, wenn zumindest zwei weitere Verbindungsstützen vorgesehen sind, die jeweils mit ihrem proximalen Ende mit einem Stützabschnitt des letzten Ringes und jeweils mit ihrem distalen Ende mit einem Stützabschnitt des vorletzten Ringes in Anlage sind. Dabei ist in einer weiteren Ausführungsform ferner bevorzugt, wenn sich die zwei weiteren Verbindungsstützen in einem Punkt kreuzen.In yet another embodiment it is preferred if at least two further connection supports are provided, each of which is in contact with a support section of the last ring with its proximal end and with a support section of the penultimate ring in each case with its distal end. In a further embodiment, it is further preferred if the two further connection supports intersect at one point.
Durch die weiteren Verbindungsstützen dieser Ausführungsformen kann die Flankenstabilität und die Flankendichtigkeit vorteilhaft erhöht werden.The flank stability and flank tightness can advantageously be increased by the further connecting supports of these embodiments.
Diese Ausführungsformen haben ferner zum Vorteil, dass die Stabilität des Stents insbesondere im distalen Bereich unterstützt wird, wodurch ebenfalls Verhakungsproblematiken der Spitzbögen beim Zurückziehen des Stents in distale Richtung vermieden werden können.These embodiments also have the advantage that the stability of the stent is supported, in particular in the distal region, which also prevents problems with hooking of the pointed arches when the stent is withdrawn in the distal direction.
Weiter ist es bevorzugt, wenn der letzte Ring und die Verbindungsstütze einstückig miteinander ausgebildet sind.It is further preferred if the last ring and the connection support are integrally formed with one another.
Diese Maßnahme ist konstruktiv von Vorteil, es ist lediglich erforderlich, einen üblichen Z-förmigen Ring zu biegen und dann eines der freien Enden in Richtung des distalen Bereiches zu verlängern, dort umzulenken und zu dem letzten Ring zurückzuführen.This measure is structurally advantageous, it is only necessary to bend a conventional Z-shaped ring and then to extend one of the free ends in the direction of the distal region, to deflect it there and to return it to the last ring.
Allgemein ist es bevorzugt, wenn der jeweilige Stützabschnitt des letzten oder vorletzten Ringes und ein mit diesem in Anlage befindlicher Abschnitt der Verbindungsstütze durch eine Presshülse miteinander verbunden sind.In general, it is preferred if the respective support section of the last or penultimate ring and a section of the connection support which is in contact therewith are connected to one another by a compression sleeve.
Diese Maßnahme ist zum einen konstruktiv von Vorteil, denn die aneinander anliegenden Drahtbereiche werden auf diese Weise miteinander verkrimpt. Diese Maßnahme ist aber auch unter Si- cherheitsaspekten von Vorteil, denn auf diese Weise werden die freien Enden sowohl des vorletzten als auch des letzten Ringes durch die Krimphülsen abgedeckt, so dass Verletzungen der Aorteninnenwand vermieden werden.On the one hand, this measure is structurally advantageous, because the wire regions lying against one another are crimped to one another in this way. However, this measure is also Safety aspects of advantage, because in this way the free ends of both the penultimate and the last ring are covered by the crimp sleeves, so that injuries to the aortic inner wall are avoided.
Weiter ist es bevorzugt, wenn die zum proximalen Ende des Stents weisenden Spitzbögen des letzten Ringes gegenüber dessen zum distalen Ende des Stents weisenden Spitzbögen nach außen gebogen sind.It is further preferred if the pointed arches of the last ring facing the proximal end of the stent are bent outwards relative to the pointed arches facing the distal end of the stent.
Bei dieser Maßnahme ist von Vorteil, dass sich die proximalen Spitzbögen der Innenwand des Aortenbogens anpassen, die in guter Näherung als Innenfläche eines Torus-Segmentes angesehen werden kann. Gleichzeitig erzeugen die nach außen gebogenen Spitzbögen durch die Elastizität des Drahtmaterials einen Druck auf die Aortenwand, der die Fixierung und Positionierung sowie die Dichtwirkung der Gefäßendoprothese, also des Stents, sicherstellt.This measure has the advantage that the proximal pointed arches adapt to the inner wall of the aortic arch, which can be regarded as a good approximation as the inner surface of a torus segment. At the same time, the outward-curved pointed arches create pressure on the aortic wall due to the elasticity of the wire material, which ensures the fixation and positioning as well as the sealing effect of the vascular endoprosthesis, i.e. the stent.
Allgemein ist es bevorzugt, wenn die Stützen und die Verbindungsstütze aus einem drahtförmigen, elastischen Material bestehen.In general, it is preferred if the supports and the connecting support consist of a wire-shaped, elastic material.
Diese Maßnahme ist an sich bekannt, sie sorgt dafür, dass der Stent zur Einführung in das Lumen der Aorta zunächst zusammengedrückt werden kann, so dass sich sein Außendurchmesser verringert. Nach dem Freisetzen des Stents expandiert sich dieser und verankert sich so in dem entsprechenden Blutgefäß.This measure is known per se; it ensures that the stent can first be compressed for insertion into the lumen of the aorta, so that its outer diameter is reduced. After the stent is released, it expands and anchors itself in the corresponding blood vessel.
Allgemein ist es bevorzugt, wenn distal zu einem distalen Spitzbogen der Verbindungsstütze an dem Mantel ein distaler Marker angebracht ist, wobei ferner vorzugsweise distal zu einem Stützabschnitt des letzen Ringes an dem Mantel ein proxi- maler Marker angeordnet ist, wobei die Marker vorzugsweise Röntgenmarker sind.In general, it is preferred if a distal to a distal pointed arch of the connection support on the jacket Marker is attached, wherein a proximal marker is also preferably arranged distal to a support section of the last ring on the jacket, the markers preferably being X-ray markers.
Bei dieser Maßnahme ist von Vorteil, dass eine Positionierungshilfe geschaffen wird, durch die während der Implantation und zur Überprüfung der Lage des im Wesentlichen von Prothesenmaterial freien Mantelbereiches gegenüber den supraaortalen Abgängen nach der Implantation die aktuelle Lage des Stents verfolgt werden kann.This measure has the advantage that a positioning aid is created, by means of which the current position of the stent can be tracked during the implantation and to check the position of the sheath region which is essentially free of prosthesis material compared to the supra-aortic outlets after the implantation.
Allgemein ist es bevorzugt, wenn das Prothesenmaterial aus textilem Material oder aus Folie besteht, wobei weiter vorzugsweise das Prothesenmaterial an den Stützen und der Verbindungsstütze durch Nähen, Kleben oder Einschmelzen befestigt ist.In general, it is preferred if the prosthesis material consists of textile material or of foil, wherein the prosthesis material is further preferably attached to the supports and the connecting support by sewing, gluing or melting.
Diese Maßnahmen sind aus dem Stand der Technik bekannt, sie ermöglichen eine schnelle und preiswerte, aber dennoch sichere Fertigung des neuen Stents.These measures are known from the prior art; they enable the new stent to be manufactured quickly and inexpensively, but nevertheless safely.
Weitere Vorteile und Merkmale ergeben sich aus der nachfolgenden Beschreibung und der beigefügten Zeichnung.Further advantages and features result from the following description and the attached drawing.
Es versteht sich, dass die vorstehend genannten und die nachstehend noch zu erläuternden Merkmale nicht nur in der jeweils angegebenen Kombination, sondern auch in anderen Kombinationen oder in Alleinstellung verwendbar sind, ohne den Rahmen der vorliegenden Erfindung zu verlassen. Ein Ausführungsbeispiel der Erfindung ist in der Zeichnung * dargestellt und wird in Bezug auf diese nachstehend näher beschrieben. Es zeigen:It goes without saying that the features mentioned above and those yet to be explained below can be used not only in the combination specified in each case, but also in other combinations or on their own without departing from the scope of the present invention. An embodiment of the invention is shown in the drawing * and is described in more detail below with reference to this. Show it:
Fig. 1 eine schematische Darstellung einer Ausführungsform eines in den absteigenden Ast der Aorta implantierten endovaskulären Stents;1 shows a schematic representation of an embodiment of an endovascular stent implanted in the descending branch of the aorta;
Fig. 2 die Stützstruktur für den Stent aus Fig. 1, jedoch ohne den umgebenden Mantel;FIG. 2 shows the support structure for the stent from FIG. 1, but without the surrounding jacket;
Fig. 3 den proximal letzten und vorletzten Ring des Stents aus Fig. 2, noch ohne Verbindung untereinander;3 shows the proximal last and penultimate ring of the stent from FIG. 2, still without connection to one another;
Fig. 4 die beiden Ringe aus Fig. 3, jetzt jedoch durch Presshülsen miteinander verbunden;4 shows the two rings from FIG. 3, but now connected to one another by pressing sleeves;
Fig. 5 eine weitere Ausführungsform des erfindungsgemäßen Stents ohne umgebenden Mantel;5 shows a further embodiment of the stent according to the invention without a surrounding jacket;
Fig. 6 noch eine weitere Ausführungsform des erfindungsgemäßen Stents mit zusätzlichen Verbindungsstützen, ebenfalls ohne umgebenden Mantel;6 shows yet another embodiment of the stent according to the invention with additional connection supports, likewise without a surrounding jacket;
Fig. 7a den proximal letzten und vorletzten Ring des Stents aus Fig. 6, mit den anzubringenden Verbindungsstützen, jedoch noch ohne die Verbindung untereinander;7a shows the proximal last and penultimate ring of the stent from FIG. 6, with the connecting supports to be attached, but still without the connection to one another;
Fig. 7b die beiden Ringe aus Fig. 7a, jetzt durch Presshülsen untereinander verbunden; Fig. 8 wiederum eine weitere Ausführungsform des erfindungsgemäßen Stents mit sich kreuzenden zusätzlichen Verbindungsstützen, ohne umgebenden Mantel;7b shows the two rings from FIG. 7a, now interconnected by pressing sleeves; FIG. 8 in turn shows a further embodiment of the stent according to the invention with intersecting additional connection supports without a surrounding jacket;
Fig. 9a den proximal letzten und vorletzten Ring des Stents aus Fig. 8, mit den anzubringenden, sich kreuzenden Verbindungsstützen, noch ohne Verbindung untereinander; undFIG. 9a the proximal last and penultimate ring of the stent from FIG. 8, with the connecting supports to be attached and crossing, still without connection to one another; and
Fig. 9b die beiden Ringe aus Fig. 9a, jetzt durch Presshülsen miteinander verbunden.Fig. 9b, the two rings from Fig. 9a, now interconnected by compression sleeves.
In Fig. 1 ist mit 10 ein Stent gezeigt, der mit seinem proximalen Ende 11 in dem Aortenbogen 12 und mit seinem distalen Ende 14 in der Aorta descendens 15 verankert ist.In FIG. 1, a stent is shown at 10, which is anchored with its proximal end 11 in the aortic arch 12 and with its distal end 14 in the descending aorta 15.
Bevor der Stent 10 näher beschrieben wird, soll zunächst das in Fig. 1 ebenfalls schematisch dargestellte Aortensystem erläutert werden.Before the stent 10 is described in more detail, the aortic system, which is also shown schematically in FIG. 1, will first be explained.
Der aufsteigende Ast 16 (A. ascendens) der Aorta ist über die in Fig. 1 nicht gezeigte Aortenwurzel (Sinus aortae) mit der ebenfalls nicht dargestellten linken Kammer des Herzens verbunden. Die Aorta ascendens 16 ist über den Aortenbogen 12 mit der Aorta descendens 15 verbunden. Im Bereich des Aortenbogens 12 gehen arterielle Kopfgefäße ab, nämlich der Arterienstamm Trun- cus brachiocephalicus 17, die Arteria carotis communis 18 und die Arteria subclavia sinistra 19.The ascending branch 16 (ascending artery) of the aorta is connected to the left ventricle of the heart, also not shown, via the aortic root (sinus aortae), which is not shown in FIG. 1. The ascending aorta 16 is connected to the descending aorta 15 via the aortic arch 12. In the area of the aortic arch 12 there are arterial head vessels, namely the trunk trunk truncus brachiocephalicus 17, the common carotid artery 18 and the subclavian sinus artery 19.
In der Aorta descendens 15 ist bei 21 ein Aneurysma dargestellt, das durch den Stent 10 sozusagen überbrückt ist. Der aus der Aorta ascendens 16 kommende Blutstrom gelangt über den Aortenbogen 12 in das proximale Ende 11 des Stents 10 und ver- lässt diesen am distalen Ende 14. Zu diesem Zweck weist der Stent 10 einen hohlzylindrischen Körper 22 auf, der durch in Fig. 1 schematisch angedeutete Ringe 23 aus mäanderförmigen Stützen 24 gebildet ist, die durch Prothesenmaterial 25 miteinander verbunden sind. Das Prothesenmaterial 25 in bekannter Weise ein textiles Material oder eine Folie und ist durch Nähen, Kleben oder Einschmelzen an den Stützen 24 befestigt.An aneurysm is shown at 21 in the descending aorta 15, which is, so to speak, bridged by the stent 10. The Blood flow coming from the ascending aorta 16 passes through the aortic arch 12 into the proximal end 11 of the stent 10 and leaves it at the distal end 14. For this purpose, the stent 10 has a hollow cylindrical body 22, which is shown schematically in FIG indicated rings 23 is formed from meandering supports 24 which are connected to each other by prosthesis material 25. The prosthesis material 25 is a textile material or a film in a known manner and is fastened to the supports 24 by sewing, gluing or melting.
Auf diese Weise wird der Durchgang durch den Stent offen gehalten, so dass sich der hohlzylindrische Körper 22 bildet.In this way, the passage through the stent is kept open, so that the hollow cylindrical body 22 is formed.
An seinem proximalen Ende 11 weist der Stent 10 einen keilförmigen, sich zum proximalen Ende 11 aufweitenden, freien Mantelbereich 27 auf, der zwischen einem proximal letzten Ring 28, einem proximal vorletzten Ring 29 sowie einer Verbindungsstütze 31 aufgespannt ist, die den letzten Ring 28 mit dem vorletzten Ring 29 verbindet.At its proximal end 11, the stent 10 has a wedge-shaped, free sheath region 27 that widens toward the proximal end 11 and is stretched between a proximal last ring 28, a proximal penultimate ring 29 and a connecting support 31 that also supports the last ring 28 connects the penultimate ring 29.
Dieser im Wesentlichen von Prothesenmaterial 25 freie Mantelbereich 27 ermöglicht es, dass aus der Aorta ascendens 16 herangeführtes Blut in die Arteria carotis communis 18 sowie die Arteria subclavia sinistra 19 gelangen kann. Außerhalb des freien Mantelbereiches 27 befindet sich jedoch zwischen dem letzten Ring 28 und dem vorletzten Ring 29 Prothesenmaterial 25, so dass sich der Stent 10 mit seinem proximalen Ende hier dicht an die bei 30 angedeutete Aorteninnenwand anschmiegt. Auf diese Weise wird verhindert, dass Blut zwischen den Stent 10 und der Aorteninnenwand 30 hindurch in den Bereich des Aneurys- mas 21 gelang, dieses ggf. weiter aufdehnt und schließlich zu einer Ruptur führt.This mantle region 27, which is essentially free of prosthesis material 25, makes it possible for blood brought from the ascending aorta 16 to reach the common carotid artery 18 and the subclavian sinus artery 19. Outside the free sheath area 27, however, there is prosthesis material 25 between the last ring 28 and the penultimate ring 29, so that the stent 10 here clings closely to the aortic inner wall indicated at 30 with its proximal end. This prevents blood from passing between the stent 10 and the aortic inner wall 30 into the region of the aneurysm. mas 21 succeeded, possibly expanding it further and finally leading to rupture.
Der konstruktive Aufbau des Stents 10 aus Fig. 1 ist in der schematischen Seitenansicht der Fig. 2 näher dargestellt, wobei aus Gründen der Übersichtlichkeit das Prothesenmaterial 25 in Fig. 2 weggelassen wurde.The structural design of the stent 10 from FIG. 1 is shown in more detail in the schematic side view of FIG. 2, the prosthesis material 25 being omitted in FIG. 2 for reasons of clarity.
Zunächst ist zu erkennen, dass in Längsrichtung 32 hintereinander der letzte Ring 28, der vorletzte Ring 29 sowie weitere Ringe 23 angeordnet sind, von denen lediglich einer dargestellt ist. Jeder dieser Ringe 23, 28, 29 weist mehrere proximale Spitzbögen 33 sowie distale Spitzbögen 34 auf, die durch schräg zur Längsrichtung 32 verlaufende Stützabschnitte 35 miteinander verbunden sind. Auf diese Weise bilden sich die aus mäanderför- mig umlaufenden Stützen 24 bestehenden Ringe 23, 28 und 29. Es sei noch erwähnt, dass sowohl die Stützen 24 als auch die Verbindungsstütze 31 aus einem drahtförmigen, elastischen Material bestehen.First of all, it can be seen that the last ring 28, the penultimate ring 29 and further rings 23 are arranged one behind the other in the longitudinal direction 32, only one of which is shown. Each of these rings 23, 28, 29 has a plurality of proximal pointed arches 33 and distal pointed arches 34 which are connected to one another by support sections 35 which run obliquely to the longitudinal direction 32. In this way, the rings 23, 28 and 29 consisting of meandering circumferential supports 24 are formed. It should also be mentioned that both the supports 24 and the connecting support 31 consist of a wire-shaped, elastic material.
Die proximalen Spitzbögen 33 des letzten Ringes 28 weisen zu den proximalen Spitzbögen 33 des vorletzten Ringes 29 einen bei 36 angedeuteten Abstand auf, der größer ist als der Abstand 37 zwischen den proximalen Spitzbögen 33 des vorletzten Ringes 29 und den proximalen Spitzbögen 33 des vorvorletzten Ringes 23. Auf diese Weise ist der Stent 10 an seinem proximalen Ende 11 biegsamer und beweglicher als in Richtung seines distalen Endes 14.The proximal pointed arches 33 of the last ring 28 are at a distance from the proximal pointed arches 33 of the penultimate ring 29 which is greater than the distance 37 between the proximal pointed arches 33 of the penultimate ring 29 and the proximal pointed arches 33 of the penultimate ring 23 In this way, the stent 10 is more flexible and movable at its proximal end 11 than in the direction of its distal end 14.
Ferner weisen die proximalen Spitzbögen 33 des letzten Ringes 28 zu den distalen Spitzbögen 34 des vorletzten Ringes 29 einen Abstand 38 auf, der größer ist als der in Fig. 1 angedeutete Abstand 39 zwischen dem Abgang der Arteria subclavia sinistra 19 und dem Abgang der Arteria carotis communis 18 vom Aortenbogen 12. Auf diese Weise kann sich der proximal letzte Ring 28 proximal von der Arteria carotis communis an der Aorteninnenwand 30 verspannen, während sich der vorletzte Ring 29 distal zu der Arteria subclavia sinistra verspannen und dort das Prothesenmaterial 25 auf dem gesamten Umfang gegen die Aorteninnenwand 30 drücken kann.Furthermore, the proximal pointed arches 33 of the last ring 28 face the distal pointed arches 34 of the penultimate ring 29 Distance 38, which is greater than the distance 39 indicated in FIG. 1 between the exit of the subclavian artery sinistra 19 and the exit of the common carotid artery 18 from the aortic arch 12. In this way, the proximal last ring 28 can be located proximally from the artery Carotis communis clamp against the aortic inner wall 30, while the penultimate ring 29 clamp distally to the subclavian sinus artery and there the prosthesis material 25 can press against the inner circumference of the aortic wall 30.
Die V-förmige Verbindungsstütze 31, die den letzten Ring 28 und den vorletzten Ring 29 miteinander verbindet, weist einen distalen Spitzbogen 41 sowie zwei sich an den Spitzbogen 41 anschließende Schenkel 42 auf, die sich V-förmig zum distalen Ende 11 des Stents 10 erweitern. Die Schenkel 42 sind mit ihren proximalen Enden 43 in Anlage mit Stützabschnitten 35 des letzten Ringes 28. Mit ihren distalen Enden 44 sind die Schenkel 42 in Anlage mit entsprechenden Stützabschnitten 35 des vorletzten Ringes 29. Die Verbindung zwischen den Stützabschnitten 35 und den jeweiligen Enden 43, 44 der Schenkel 42 erfolgt über Presshülsen 45, die auch die mäanderförmigen Stützen 24 bspw. des Ringes 23 zu ihrem Z-förmigen Verlauf schließen.The V-shaped connecting support 31, which connects the last ring 28 and the penultimate ring 29 to one another, has a distal pointed arch 41 and two legs 42 adjoining the pointed arch 41, which extend in a V-shape to the distal end 11 of the stent 10 , The legs 42 have their proximal ends 43 in contact with support sections 35 of the last ring 28. With their distal ends 44, the legs 42 are in contact with corresponding support sections 35 of the penultimate ring 29. The connection between the support sections 35 and the respective ends 43 , 44 of the leg 42 takes place via pressing sleeves 45, which also close the meandering supports 24, for example of the ring 23, to their Z-shaped course.
In Fig. 3 sind der letzte Ring 28 sowie der vorletzte Ring 29 unmittelbar nach der Fertigung, also noch vor der Verbindung miteinander dargestellt.In Fig. 3, the last ring 28 and the penultimate ring 29 are shown immediately after manufacture, that is, before the connection with each other.
Es ist in Fig. 3 links zu erkennen, dass der letzte Ring 28 und die Verbindungsstütze 31 einstückig miteinander ausgebildet sind. Ferner ist in Fig. 3 rechts zu erkennen, dass dem vorletzten Ring 29 sozusagen ein distaler Spitzbogen 34 fehlt, was durch eine bei 48 angedeutete Lücke dargestellt ist. Diese Lücke wird jetzt durch den distalen Spitzbogen 41 der Verbindungsstütze 31 gefüllt.It can be seen on the left in FIG. 3 that the last ring 28 and the connecting support 31 are formed in one piece with one another. Furthermore, it can be seen in FIG. 3 on the right that the penultimate ring 29 lacks, so to speak, a distal pointed arch 34, which is represented by a gap indicated at 48. This gap is now filled by the distal pointed arch 41 of the connection support 31.
Der letzte Ring 28 wird beginnend bei seinem freien Ende 49 durch mehrfaches Z-förmiges Umbiegen des entsprechenden Drahtmaterials gebildet, so dass sich die proximalen und distalen Spitzbögen 33 und 34 bilden. Wenn der Ring 28 geschlossen ist, wird das Drahtmaterial distal weitergeführt und am distalen Spitzbogen 41 umgebogen und zurückgeführt zum Stützabschnitt 35, wo der Draht abgeschnitten wird, so dass sich das zweite freie Ende 50 des einstückigen Gebildes ergibt, das sowohl den letzten Ring 28 als auch die Verbindungsstütze 31 darstellt. Der vorletzte Ring 29 weist entsprechend zwei freie Enden 51 und 52 auf, die beiderseits der Lücke 48 liegen.The last ring 28 is formed starting at its free end 49 by multiple Z-shaped bending of the corresponding wire material, so that the proximal and distal arches 33 and 34 are formed. When the ring 28 is closed, the wire material is advanced distally and bent at the distal arch 41 and returned to the support section 35 where the wire is cut off to give the second free end 50 of the one-piece structure which is both the last ring 28 and also represents the connection support 31. The penultimate ring 29 accordingly has two free ends 51 and 52, which are located on both sides of the gap 48.
Der letzte Ring 28 sowie der vorletzte Ring 29 werden jetzt so zusammengeführt, wie dies in Fig. 4 dargestellt ist, wobei an den freien Enden 49 bis 52 jeweils eine Presshülse 45 aufgeschoben wird, die zum einen die Schenkel 42 mit den entsprechenden Stützabschnitten 35 verbindet und zum anderen die freien Enden 49 bis 52 verdeckt, so dass eine Verletzung der Aorteninnenwand vermieden wird.The last ring 28 and the penultimate ring 29 are now brought together as shown in FIG. 4, with a compression sleeve 45 being pushed onto the free ends 49 to 52, which on the one hand connects the legs 42 to the corresponding support sections 35 and on the other hand, the free ends 49 to 52 are covered, so that damage to the inner wall of the aortic is avoided.
Der letzte Ring 28 sowie der vorletzte Ring 29 bildet zusammen mit der Verbindungsstütze 31 eine Fixierungsstruktur, die am proximalen Ende 11 des Stents 10 vorgesehen ist. Mit dieser Fixierungsstruktur kann nun auch die Aorteninnenwand gegenüber und proximal des Abganges der Arteria subclavia sinistra als Fixierungs- und Dichtungsfläche genutzt werden, ohne dass dieser Abgang verschlossen wird. Wenn der neue Stent in dem dafür vorgesehenen Bereich implantiert wird, ist es jetzt nicht mehr erforderlich, vorher einen belastenden Serviceeingriff durchzuführen.The last ring 28 and the penultimate ring 29 together with the connection support 31 form a fixation structure which is provided at the proximal end 11 of the stent 10. With this fixation structure, the inner wall of the aorta opposite and proximal to the outlet of the subclavian artery can also be used as a fixation and sealing surface without this outlet being closed. If the new stent in it for that implanted area, it is no longer necessary to carry out a stressful service intervention beforehand.
Es sei noch erwähnt, dass die proximalen Spitzbögen 33 des letzten Ringes 28 gegenüber den distalen Spitzbögen 34 nach außen aufgeweitet bzw. nach außen gebogen sind, was in Fig. 2 oben zu erkennen ist. Dadurch passen sich die Spitzbögen 33 der Aorteninnenwand 30 an und erzeugen gleichzeitig durch die Elastizität des Drahtmaterials einen Druck auf die Aorteninnenwand 30, der die Fixierung und Positionierung sowie die Dichtwirkung der Gefäßendoprothese sicherstellt.It should also be mentioned that the proximal pointed arches 33 of the last ring 28 are widened or bent outwards relative to the distal pointed arches 34, which can be seen in FIG. 2 at the top. As a result, the pointed arches 33 adapt to the aortic inner wall 30 and at the same time generate pressure on the inner aortic wall 30 due to the elasticity of the wire material, which ensures the fixation and positioning as well as the sealing effect of the vascular endoprosthesis.
In Fig. 1 ist ferner zu erkennen, dass der letzte Ring 28 nach vorne gebogen werden kann, wodurch sich die Schenkel 42 der Verbindungsstütze 31 nach außen spreizen und eng an die Aorteninnenwand 30 anlegen. Dies wird noch unterstützt durch den Druck, den die Aorteninnenwand auf den letzten Ring 28 ausübt, der unter Druck ebenfalls die Schenkel 42 der Verbindungsstütze 31 nach außen spreizt. Auf diese Weise wird das dort befestigte Prothesenmaterial nach außen an die Aorteninnenwand 30 gedrückt und bildet so eine Abdichtung des Blutstromes gegen das Volumen des Aneurysma 21.In FIG. 1 it can also be seen that the last ring 28 can be bent forward, as a result of which the legs 42 of the connecting support 31 spread outward and fit closely against the aortic inner wall 30. This is further supported by the pressure exerted by the inner wall of the aortic on the last ring 28, which also expands the legs 42 of the connecting support 31 to the outside under pressure. In this way, the prosthesis material fastened there is pressed outward against the aortic inner wall 30 and thus forms a seal of the blood flow against the volume of the aneurysm 21.
Der keilförmig vom Prothesenmaterial 25 frei bleibende Bereich 27 sorgt für die entsprechende Versorgung von Arteria subclavia sinistra 19 und Arteria carotis communis 18.The area 27 remaining free from the prosthesis material 25 ensures the appropriate supply of the subclavian sinus artery 19 and the common carotid artery 18.
Als Positionierungshilfe während der Implantation und zur Überprüfung der Lage des ungedeckten Prothesenbereiches, also des freien Mantelbereiches 27 gegenüber den supraaortalen Abgängen 19 und 18 nach der Implantation dienen zwei Röntgenmarker 46 und 47, die in Fig. 1 zu sehen sind. Der Marker 46 ist ein distaler Marker, der distral zu dem distalen Spitzbogen 41 der Verbindungsstütze 31 angeordnet ist. Der Marker 47 ist dagegen ein proximaler Marker, der distal zu einem Stützabschnitt des letzten Ringes 28 an dem Mantel 26 befestigt ist.As a positioning aid during the implantation and for checking the position of the uncovered prosthesis area, that is to say the free jacket area 27 relative to the supraaortic outlets 19 and 18 after the implantation serve two X-ray markers 46 and 47, which can be seen in FIG. 1. The marker 46 is a distal marker, which is arranged distral to the distal pointed arch 41 of the connecting support 31. The marker 47, on the other hand, is a proximal marker that is attached distally to a support section of the last ring 28 on the jacket 26.
Eine weitere Ausführungsform des erfindungsgemäßen Stents ist in einer schematischen Seitenansicht in Fig. 5 dargestellt, wobei auch hier - wie in Fig. 2 - aus Gründen der Übersichtlichkeit das Prothesenmaterial 25 weggelassen wurde. In den Fig. 5 bis 9a wurden zur Bezeichnung der gleichen Elemente der Stents die gleichen Bezugszeichen wie in Fig. 2 verwendet.A further embodiment of the stent according to the invention is shown in a schematic side view in FIG. 5, the prosthesis material 25 also being omitted here, as in FIG. 2, for reasons of clarity. 5 to 9a, the same reference numerals as in Fig. 2 have been used to designate the same elements of the stents.
In Fig. 5 ist zu erkennen, dass auch bei dieser Ausführungsform in Längsrichtung 32 hintereinander der letzte Ring 28, der vorletzte Ring 29 sowie weitere Ringe 23 angeordnet sind, von denen lediglich einer dargestellt ist. Es ist ferner zu erkennen, dass der letzte Ring 28 einen proximalen Spitzbogen 33 - und dadurch auch einen distalen Spitzbogen 34 - weniger aufweist als der vorletzte Ring 29 und als der Ring 23. Bei dieser Ausführungsform fehlt demnach im Vergleich zu Fig. 2 der distale Spitzbogen 39 (siehe Fig. 2).5 that in this embodiment too the last ring 28, the penultimate ring 29 and further rings 23 are arranged one behind the other in the longitudinal direction 32, only one of which is shown. It can also be seen that the last ring 28 has a proximal pointed arch 33 - and thus also a distal pointed arch 34 - less than the penultimate ring 29 and than the ring 23. In this embodiment, the distal one is therefore missing in comparison to FIG. 2 Ogive 39 (see Fig. 2).
In Fig. 6 ist eine weitere Ausführungsform des erfindungsgemäßen Stents dargestellt, wobei diese Ausführungsform im Vergleich zur Ausführungsform aus Fig. 2 zusätzliche Verbindungsstützen 61 und 62 aufweist. Die Verbindungsstützen 61 und 62 sind mit ihrem proximalen Ende 63 jeweils mit einem Stützabschnitt 35 des letzten Ringes 28 und mit ihrem distalen Ende 64 jeweils mit einem Stützabschnitt 35 des vorletzten Ringes 29 in Anlage gebracht. In der Fig. 6 ist zu erkennen, dass dadurch die zusätzlichen Verbindungsstützen 61 und 62 eine Art Flankenverstärkung für den Stent darstellen.FIG. 6 shows a further embodiment of the stent according to the invention, this embodiment having additional connection supports 61 and 62 in comparison to the embodiment from FIG. 2. The connecting supports 61 and 62 are each with their proximal end 63 with a support section 35 of the last ring 28 and with their distal end 64 each with a support section 35 of the penultimate ring 29 in Plant brought. It can be seen in FIG. 6 that the additional connection supports 61 and 62 thereby represent a type of flank reinforcement for the stent.
In Fig. 7a sind der letzte Ring 28 sowie der vorletzte Ring 29 unmittelbar nach der Fertigung, also noch vor der Verbindung miteinander, dargestellt. In Fig. 7a ist - wie in Fig. 3 - zu erkennen, dass der letzte Ring 28 und die Verbindungsstütze 31 einstückig miteinander ausgebildet sind. Die zusätzlichen Verbindungsstützen 61 und 62 werden mit ihrem proximalen Ende 63 mit einem Stützabschnitt 35 des letzten Ringes 28 in Anlage gebracht, was durch die Pfeile 65 angedeutet ist, sowie die distalen Enden 64 jeweils mit einem Stützabschnitt 35 des vorletzten Ringes 29, was durch die Pfeile 66 angedeutet ist.In Fig. 7a, the last ring 28 and the penultimate ring 29 are shown immediately after manufacture, that is, before they are connected to one another. 7a - as in FIG. 3 - it can be seen that the last ring 28 and the connecting support 31 are formed in one piece with one another. The additional connecting supports 61 and 62 are brought into contact with their proximal end 63 with a support section 35 of the last ring 28, which is indicated by the arrows 65, and the distal ends 64 each with a support section 35 of the penultimate ring 29, which is indicated by the Arrows 66 is indicated.
In Fig. 7b ist zu erkennen, dass die beiden Ringe 28 und 29 zusammengeführt sind, wobei die Enden jeweils über Presshülsen 68 mit den entsprechenden Stützabschnitten 35 verbunden sind, so dass Verletzungen der Aorteninnenwand vermieden werden.In FIG. 7b it can be seen that the two rings 28 and 29 are brought together, the ends each being connected to the corresponding support sections 35 via press sleeves 68, so that injuries to the aortic inner wall are avoided.
In Fig. 8 ist noch eine weitere Ausführungsform des erfindungsgemäßen Stents dargestellt, wobei hier wie in Fig. 6 ebenfalls zwei zusätzliche Verbindungsstützen 71 und 72 vorgesehen sind, die sich aber in einem Punkt 77 kreuzen.A further embodiment of the stent according to the invention is shown in FIG. 8, two additional connection supports 71 and 72 also being provided here as in FIG. 6, but which intersect at a point 77.
Ähnlich wie in Fig. 7a ist in Fig. 9a zu erkennen, dass die sich kreuzenden Verbindungsstützen 71 und 72 jeweils über ihr proximales Ende 73 mit einem Stützabschnitt 35 des letzten Ringes 28 in Anlage gebracht werden, was durch die Pfeile 75 angedeutet ist, und mit ihrem distalen Ende 74 mit einem Stütz- abschnitt 35 des vorletzten Ringes 29, was mit den Pfeilen 76 angedeutet ist.Similar to FIG. 7a, it can be seen in FIG. 9a that the intersecting connecting supports 71 and 72 are each brought into abutment via their proximal end 73 with a support section 35 of the last ring 28, which is indicated by the arrows 75, and with its distal end 74 with a support section 35 of the penultimate ring 29, which is indicated by the arrows 76.
In Fig. 9b ist gezeigt, zu erkennen, dass die beiden Ringe 28 und 29 zusammengeführt sind, wobei die Enden der Verbindungsstützen 71 und 72 durch Anbringen von Presshülsen 68 mit den jeweiligen Stützabschnitten 35 des letzten Ringes 28 bzw. des vorletzten Ringes 29 verbunden werden. 9b shows that the two rings 28 and 29 are brought together, the ends of the connecting supports 71 and 72 being connected to the respective support sections 35 of the last ring 28 and the penultimate ring 29 by attaching compression sleeves 68 ,

Claims

Patentansprüche claims
1. Stent zur Implantation in ein Blutgefäß (15), insbesondere im Bereich des Aortenbogens (12), mit in seiner Längsrichtung (32) hintereinander angeordneten Ringen (23, 28, 29) aus mäanderförmig umlaufenden Stützen (24) und einem an den Ringen (23, 28, 29) befestigten und diese verbindenden Prothesenmaterial (25), das einen hohlzylindrischer Körper mit umfänglich im Wesentlichen geschlossenen Mantel (21) bildet, dadurch gekennzeichnet, dass zwischen dem letzten (28) und dem vorletzten (29) Ring am proximalen Ende (14) des Stents (10) zumindest eine Verbindungsstütze (31) vorgesehen ist, die diese beiden Ringe (28, 29) miteinander verbindet.1. Stent for implantation in a blood vessel (15), in particular in the area of the aortic arch (12), with rings (23, 28, 29) arranged one behind the other in its longitudinal direction (32) and consisting of meandering supports (24) and one on the rings (23, 28, 29) attached and connecting these prosthesis material (25), which forms a hollow cylindrical body with a circumferentially substantially closed jacket (21), characterized in that between the last (28) and the penultimate (29) ring on the proximal At least one connection support (31) is provided at the end (14) of the stent (10) and connects these two rings (28, 29) to one another.
2. Stent nach Anspruch 1, dadurch gekennzeichnet, dass zwischen dem letzten und dem vorletzten Ring (28, 29) im Bereich der Verbindungsstütze (31) ein im Wesentlichen von Prothesenmaterial (25) freier Mantelbereich (27) aufgespannt ist.2. Stent according to claim 1, characterized in that between the last and the penultimate ring (28, 29) in the area of the connecting support (31) is a substantially free of prosthesis material (25) jacket area (27) is stretched.
3. Stent nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass die Verbindungsstütze (31) V-förmig ausgebildet ist.3. Stent according to claim 1 or 2, characterized in that the connection support (31) is V-shaped.
4. Stent nach Anspruch 2 oder 3, dadurch gekennzeichnet, dass der im Wesentlichen von Prothesenmaterial (25) freie Man- telbereich (27) sich zum proximalen Ende (11) des Stents (10) keilförmig aufweitet.4. Stent according to claim 2 or 3, characterized in that the man-substantially free of prosthesis material (25) telregion (27) widens in a wedge shape to the proximal end (11) of the stent (10).
Stent nach einem der Ansprüche 1 bis 4, dadurch gekennzeichnet, dass die Stützen (24) einen Z-förmigen Verlauf mit abwechselnd zum proximalen (11) und zum distalen (14) Ende des Stents (10) weisenden Spitzbögen (33, 34) aufweisen, die durch schräg zur Längsrichtung (32) verlaufende Stützabschnitte (35) miteinander verbunden sind.Stent according to one of claims 1 to 4, characterized in that the supports (24) have a Z-shaped course with pointed arches (33, 34) pointing alternately to the proximal (11) and the distal (14) end of the stent (10) which are connected to one another by support sections (35) which run obliquely to the longitudinal direction (32).
Stent nach Anspruch 5, dadurch gekennzeichnet, dass die proximalen Spitzbögen (33) des letzten Ringes (28) zu den proximalen Spitzbögen (33) des vorletzten Ringes (29) eines Abstand (36) aufweisen, der größer ist als der Abstand (37) zwischen den proximalen Spitzbögen (33) des vorletzten Ringes (29) und den proximalen Spitzbögen (33) des vorvorletzten Ringes (23).Stent according to claim 5, characterized in that the proximal pointed arches (33) of the last ring (28) to the proximal pointed arches (33) of the penultimate ring (29) have a distance (36) which is greater than the distance (37) between the proximal pointed arches (33) of the penultimate ring (29) and the proximal pointed arches (33) of the penultimate ring (23).
Stent nach Anspruch 5 oder 6, dadurch gekennzeichnet, dass die proximalen Spitzbögen (33) des letzten Ringes (28) zu den distalen Spitzbögen (34) des vorletzten Ringes (29) eines Abstand (38) aufweisen, der größer ist als der Abstand (38) zwischen dem Abgang der A. subclavia sinister (19) und dem Abgang der A. carotis communis (18) vom Aortenbogen ( 12 ) .Stent according to claim 5 or 6, characterized in that the proximal pointed arches (33) of the last ring (28) to the distal pointed arches (34) of the penultimate ring (29) have a distance (38) which is greater than the distance ( 38) between the branch of the subclavian sinus artery (19) and the branch of the common carotid artery (18) from the aortic arch (12).
Stent nach einem der Ansprüche 5 bis 7, dadurch gekennzeichnet, dass ein zum distalen Ende (14) des Stents (10) weisender Spitzbogen (41) des vorletzten Ringes (29) mit einem Spitzbogen der Verbindungsstütze (31) in Anlage ist. Stent according to one of claims 5 to 7, characterized in that a pointed arch (41) of the penultimate ring (29) facing the distal end (14) of the stent (10) is in contact with a pointed arch of the connecting support (31).
9. Stent nach Anspruch 8, dadurch gekennzeichnet, dass der zum distalen Ende (14) des Stents (10) weisende Spitzbogen (41) des vorletzten Ringes (29) zumindest teilweise durch den Spitzbogen (1) der Verbindungsstütze (31) gebildet ist.9. Stent according to claim 8, characterized in that the pointed arch (41) of the penultimate ring (29) facing the distal end (14) of the stent (10) is at least partially formed by the pointed arch (1) of the connecting support (31).
10. Stent nach einem der Ansprüche 5 bis 9, dadurch gekennzeichnet, dass die Verbindungsstütze (31) zwei Schenkel (42) aufweist, die an ihrem proximalen Ende (43) jeweils mit einem Stützabschnitt (35) des letzten Ringes (28) in Anlage sind.10. Stent according to one of claims 5 to 9, characterized in that the connecting support (31) has two legs (42), each at its proximal end (43) with a support section (35) of the last ring (28) in contact are.
11. Stent nach einem der Ansprüche 5 bis 10, dadurch gekennzeichnet, dass die Verbindungsstütze (31) zwei Schenkel (42) aufweist, die an ihrem distalen Ende (44) jeweils mit einem Stützabschnitt (35) des vorletzten Ringes (29) in Anlage sind.11. Stent according to one of claims 5 to 10, characterized in that the connecting support (31) has two legs (42), each at its distal end (44) with a support section (35) of the penultimate ring (29) in contact are.
12. Stent nach einem der Ansprüche 1 bis 11, dadurch gekennzeichnet, dass die Anzahl der Spitzbögen (33; 34) des letzten Ringes (28) geringer ist als die Anzahl der Spitzbögen (33, 34) des vorletzten Ringes (29).12. Stent according to one of claims 1 to 11, characterized in that the number of pointed arches (33; 34) of the last ring (28) is less than the number of pointed arches (33, 34) of the penultimate ring (29).
13. Stent nach einem der Ansprüche 5 bis 11, dadurch gekennzeichnet, dass zumindest zwei weitere Verbindungsstützen (61, 62; 71, 72) vorgesehen sind, die mit ihrem proximalen Ende (63) jeweils mit einem Stützabschnitt (35) des letzten Ringes (28) und mit ihrem distalen Ende (64) jeweils mit einem Stützabschnitt (35) des vorletzten Ringes (29) in Anlage sind. 13. Stent according to one of claims 5 to 11, characterized in that at least two further connection supports (61, 62; 71, 72) are provided, each of which has a proximal end (63) with a support section (35) of the last ring ( 28) and with their distal end (64) are each in contact with a support section (35) of the penultimate ring (29).
14. Stent nach Anspruch 13, dadurch gekennzeichnet, dass die Verbindungsstützen (71, 72) über ihr jeweils proximales Ende (73) und jeweils distales Ende (74) mit den Stützabschnitten (35) des letzten (28) und vorletzten (29) Ringes derart in Anlage sind, dass sich die Verbindungsstützen (71, 72) in einem Punkt (77) kreuzen.14. Stent according to claim 13, characterized in that the connection supports (71, 72) via their respective proximal end (73) and each distal end (74) with the support sections (35) of the last (28) and penultimate (29) ring are in such a way that the connection supports (71, 72) intersect at a point (77).
15. Stent nach einem der Ansprüche 1 bis 14, dadurch gekennzeichnet, dass der letzte Ring (28) und die Verbindungsstütze (31) einstückig miteinander ausgebildet sind.15. Stent according to one of claims 1 to 14, characterized in that the last ring (28) and the connecting support (31) are integrally formed with one another.
16. Stent nach einem der Ansprüche 5 bis 15, dadurch gekennzeichnet, dass der jeweilige Stützabschnitt (35) des letzten (28) oder vorletzten (29) Ringes und ein mit diesem in Anlage befindlicher Abschnitt der zumindest einen Verbindungsstütze (31; 61, 62; 71, 72) durch eine Presshülse (45; 68) miteinander verbunden sind.16. Stent according to one of claims 5 to 15, characterized in that the respective support section (35) of the last (28) or penultimate (29) ring and a section of the at least one connection support (31; 61, 62) in contact therewith ; 71, 72) are connected to each other by a press sleeve (45; 68).
17. Stent nach einem der Ansprüche 5 bis 16, dadurch gekennzeichnet, dass die zum proximalen Ende (11) des Stents (10) weisenden Spitzbögen (33) des letzten Ringes (28) gegenüber dessen zum distalen Ende (14) des Stents (10) weisenden Spitzbögen (34) nach außen gebogen sind.17. Stent according to one of claims 5 to 16, characterized in that the pointed arches (33) of the last ring (28) facing the proximal end (11) of the stent (10) opposite the distal end (14) of the stent (10 ) pointing pointed arches (34) are bent outwards.
18. Stent nach einem der Ansprüche 1 bis 17, dadurch gekennzeichnet, dass die Stützen (24) und die zumindest eine Verbindungsstütze (31; 61, 62; 71, 72) aus einem drahtförmigen, elastischen Material bestehen.18. Stent according to one of claims 1 to 17, characterized in that the supports (24) and the at least one connecting support (31; 61, 62; 71, 72) consist of a wire-shaped, elastic material.
19. Stent nach einem der Ansprüche 1 bis 18, dadurch gekennzeichnet, dass distal zu einem distalen Spitzbogen (41) der Verbindungsstütze (31) an dem Mantel (26) ein distaler Marker (46) angeordnet ist.19. Stent according to one of claims 1 to 18, characterized in that distal to a distal pointed arch (41) the distal marker (46) is arranged on the jacket (26) of the connection support (31).
20. Stent nach einem der Ansprüche 5 bis 19, dadurch gekennzeichnet, dass distal zu einem Stützabschnitt (35) des letzten Ringes (28) an dem Mantel (26) ein proximaler Marker (47) angeordnet ist.20. Stent according to one of claims 5 to 19, characterized in that a proximal marker (47) is arranged distally to a support section (35) of the last ring (28) on the jacket (26).
21. Stent nach Anspruch 19 oder 20, dadurch gekennzeichnet, dass der Marker (46, 47) ein Röntgenmarker ist.21. Stent according to claim 19 or 20, characterized in that the marker (46, 47) is an X-ray marker.
22. Stent nach einem der Ansprüche 1 bis 21, dadurch gekennzeichnet, dass das Prothesenmaterial (25) aus textilem Material oder aus Folie besteht.22. Stent according to one of claims 1 to 21, characterized in that the prosthesis material (25) consists of textile material or of film.
23. Stent nach einem der Ansprüche 1 bis 22, dadurch gekennzeichnet, dass das Prothesenmaterial (25) an den Stützen (14) und der zumindest einen Verbindungsstütze (31; 61,62; 71, 72) durch Nähen, Kleben oder Einschmelzen befestigt ist. 23. Stent according to one of claims 1 to 22, characterized in that the prosthesis material (25) on the supports (14) and the at least one connecting support (31; 61,62; 71, 72) is attached by sewing, gluing or melting ,
EP04763937.2A 2003-08-12 2004-08-10 Stent for implantation in a blood vessel, especially in the region of the aortic arch Active EP1653883B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10337739A DE10337739B4 (en) 2003-08-12 2003-08-12 Stent for implantation in a blood vessel, especially in the area of the aortic arch
PCT/EP2004/008916 WO2005013854A1 (en) 2003-08-12 2004-08-10 Stent for implantation in a blood vessel, especially in the region of the aortic arch

Publications (2)

Publication Number Publication Date
EP1653883A1 true EP1653883A1 (en) 2006-05-10
EP1653883B1 EP1653883B1 (en) 2015-01-21

Family

ID=34129588

Family Applications (1)

Application Number Title Priority Date Filing Date
EP04763937.2A Active EP1653883B1 (en) 2003-08-12 2004-08-10 Stent for implantation in a blood vessel, especially in the region of the aortic arch

Country Status (5)

Country Link
US (1) US8668729B2 (en)
EP (1) EP1653883B1 (en)
DE (1) DE10337739B4 (en)
ES (1) ES2532371T3 (en)
WO (1) WO2005013854A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116919683A (en) * 2023-09-15 2023-10-24 北京华脉泰科医疗器械股份有限公司 Branched endovascular prosthesis and endovascular prosthesis delivery device

Families Citing this family (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8382821B2 (en) 1998-12-03 2013-02-26 Medinol Ltd. Helical hybrid stent
US20040267349A1 (en) 2003-06-27 2004-12-30 Kobi Richter Amorphous metal alloy medical devices
US9155639B2 (en) * 2009-04-22 2015-10-13 Medinol Ltd. Helical hybrid stent
US20060161241A1 (en) * 2005-01-14 2006-07-20 Denise Barbut Methods and devices for treating aortic atheroma
DE602006019753D1 (en) * 2005-09-01 2011-03-03 Medtronic Vascular Inc METHOD AND APPARATUS FOR THE TREATMENT OF ANEURYSMS OF A. THORACICA
CN101500516B (en) * 2006-08-02 2011-08-24 马尼株式会社 Stent
US20080109055A1 (en) * 2006-11-02 2008-05-08 Sage Medical Technologies, Inc. Implant for aortic dissection and methods of use
GB2470041B (en) * 2009-05-06 2011-05-18 Cook William Europ Stent graft
DE102012100754A1 (en) 2012-01-31 2013-08-01 Jotec Gmbh Modular stent graft
GB2499377B (en) 2012-02-01 2014-04-30 Cook Medical Technologies Llc Implantable medical device
US8998975B2 (en) * 2012-11-12 2015-04-07 Medtronic Vascular, Inc. Helical stent with orthogonal end and method of forming stent
DE102012111223A1 (en) 2012-11-21 2014-05-22 Jotec Gmbh Vascular implant with asymmetric stent springs
US10034784B2 (en) 2013-04-17 2018-07-31 Gilbert H. L. Tang Heart valve and endovascular graft components and method for delivery
GB2516928A (en) * 2013-08-07 2015-02-11 Vascutek Ltd Prosthesis Device
CN103598929B (en) * 2013-11-28 2016-04-20 先健科技(深圳)有限公司 Thoracic aorta covered bracket
DE102014114747A1 (en) 2014-10-10 2016-04-14 Jotec Gmbh Vascular prostheses system
DE102014116012A1 (en) 2014-11-04 2016-05-04 Jotec Gmbh Modular stent graft system
CA3007346C (en) 2015-01-11 2020-08-18 Ascyrus Medical, Llc Hybrid device for surgical aortic repair and method of using the same
EP3244828B1 (en) * 2015-01-12 2019-12-18 Endospan Ltd. Self-curving stent-graft
US10004617B2 (en) 2015-10-20 2018-06-26 Cook Medical Technologies Llc Woven stent device and manufacturing method
DE102015123000A1 (en) 2015-12-30 2017-07-06 Jotec Gmbh Self-expanding vascular prosthesis
DE102016102008A1 (en) 2016-02-04 2017-08-10 Jotec Gmbh Vascular prosthesis with side branches
CN108261253B (en) * 2016-12-31 2021-06-15 先健科技(深圳)有限公司 Covered stent
CN106726038B (en) * 2017-01-23 2018-05-25 中国人民解放军第二军医大学 A kind of aorta ascendens inner cavity insulation transplantation device
US11395734B2 (en) 2017-04-07 2022-07-26 Shanghai Joy Medical Devices Co., Ltd. Prosthetic valve and prosthetic valve implanting method
DE102017111964A1 (en) 2017-05-31 2018-12-06 Jotec Gmbh Stentgraft with pockets
US9848906B1 (en) 2017-06-20 2017-12-26 Joe Michael Eskridge Stent retriever having an expandable fragment guard
CN209107691U (en) * 2017-07-03 2019-07-16 深圳市科奕顿生物医疗科技有限公司 A kind of self-inflated intraluminal stent
DE102017120819A1 (en) 2017-09-08 2019-03-14 Jotec Gmbh Intraluminal vascular prosthesis system
US10959864B2 (en) 2018-01-11 2021-03-30 Cook Medical Technologies Llc Barbed wire stent
EP3941392A1 (en) 2019-03-20 2022-01-26 Inqb8 Medical Technologies, LLC Aortic dissection implant

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5843167A (en) * 1993-04-22 1998-12-01 C. R. Bard, Inc. Method and apparatus for recapture of hooked endoprosthesis
EP0657147B1 (en) * 1993-11-04 1999-08-04 C.R. Bard, Inc. Non-migrating vascular prosthesis
US5800521A (en) * 1994-11-09 1998-09-01 Endotex Interventional Systems, Inc. Prosthetic graft and method for aneurysm repair
US5683449A (en) * 1995-02-24 1997-11-04 Marcade; Jean Paul Modular bifurcated intraluminal grafts and methods for delivering and assembling same
ATE314022T1 (en) * 1995-06-01 2006-01-15 Meadox Medicals Inc IMPLANTABLE INTRALUMINAL PROSTHESIS
FR2737404B1 (en) * 1995-08-03 1997-09-19 Braun Celsa Sa PROSTHESIS IMPLANTABLE IN A HUMAN OR ANIMAL CONDUCT, SUCH AS A WALL Expander, OR ANEURISM PROSTHESIS
DK171865B1 (en) * 1995-09-11 1997-07-21 Cook William Europ Expandable endovascular stent
US5591195A (en) * 1995-10-30 1997-01-07 Taheri; Syde Apparatus and method for engrafting a blood vessel
US6030414A (en) * 1997-11-13 2000-02-29 Taheri; Syde A. Variable stent and method for treatment of arterial disease
AUPP083597A0 (en) * 1997-12-10 1998-01-08 William A Cook Australia Pty Ltd Endoluminal aortic stents
US6395018B1 (en) * 1998-02-09 2002-05-28 Wilfrido R. Castaneda Endovascular graft and process for bridging a defect in a main vessel near one of more branch vessels
US6280467B1 (en) * 1998-02-26 2001-08-28 World Medical Manufacturing Corporation Delivery system for deployment and endovascular assembly of a multi-stage stented graft
JP4399585B2 (en) * 1998-06-02 2010-01-20 クック インコーポレイティド Multi-sided medical device
US6071307A (en) * 1998-09-30 2000-06-06 Baxter International Inc. Endoluminal grafts having continuously curvilinear wireforms
FR2797389B1 (en) * 1999-08-09 2001-11-30 Novatech Inc BIFURCED AORTIC PROSTHESIS
DE60127530T2 (en) * 2000-02-03 2007-12-13 Cook Inc., Bloomington IMPLANTABLE VASCULAR DEVICE
US6319278B1 (en) * 2000-03-03 2001-11-20 Stephen F. Quinn Low profile device for the treatment of vascular abnormalities
DE10065824B4 (en) 2000-12-28 2018-10-31 Jotec Gmbh Endovascular stent for implantation in the ascending branch of the aorta
ES2223759T3 (en) * 2001-03-27 2005-03-01 William Cook Europe Aps AORTIC GRAFT DEVICE.
US7147661B2 (en) * 2001-12-20 2006-12-12 Boston Scientific Santa Rosa Corp. Radially expandable stent
EP1336393A3 (en) * 2002-02-14 2003-11-19 John S. Geis Stent-prosthesis, delivery device and delivery set for stent-prosthesis

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2005013854A1 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116919683A (en) * 2023-09-15 2023-10-24 北京华脉泰科医疗器械股份有限公司 Branched endovascular prosthesis and endovascular prosthesis delivery device
CN116919683B (en) * 2023-09-15 2023-12-08 北京华脉泰科医疗器械股份有限公司 Branched endovascular prosthesis and endovascular prosthesis delivery device

Also Published As

Publication number Publication date
DE10337739A1 (en) 2005-03-10
DE10337739B4 (en) 2009-11-26
EP1653883B1 (en) 2015-01-21
US8668729B2 (en) 2014-03-11
WO2005013854A1 (en) 2005-02-17
ES2532371T3 (en) 2015-03-26
US20060195177A1 (en) 2006-08-31

Similar Documents

Publication Publication Date Title
EP1653883B1 (en) Stent for implantation in a blood vessel, especially in the region of the aortic arch
DE69826444T2 (en) ENDOVASCULAR IMPLANT TO IMPROVE AN ANEURYSMAS OF THE ABDOMINALAORTA
DE69518435T3 (en) A branching graft manufacturing system
DE69635659T2 (en) IMPLANTABLE INTRALUMINARY PROSTHESIS
DE60023769T2 (en) balloon catheter
DE60019009T2 (en) Intraluminal expandable endoprosthesis
EP2809265B1 (en) Modular stent graft
EP3203931B1 (en) Vascular prosthesis system
EP2809267B1 (en) Intraluminal vascular prosthesis
DE10065824B4 (en) Endovascular stent for implantation in the ascending branch of the aorta
EP3215055B1 (en) Modular stent graft system
EP1648342A1 (en) Woven stent to be implanted in a blood vessel
EP3897454B1 (en) Device for feeding and setting an implant into a blood vessel
EP3060177B1 (en) Vascular implant having portions of different radial force
DE10342757A1 (en) Stent with terminal anchoring elements
DE102015123000A1 (en) Self-expanding vascular prosthesis
EP3678589A1 (en) Intraluminal vessel prosthesis system
EP3410983A1 (en) Vascular prosthesis having side branches
EP3630009A1 (en) Stent graft with pockets
EP2846731B1 (en) Intraluminal vascular prosthesis having in-situ fenestration
DE102010009802A1 (en) Radially expandable stent
EP3694449A1 (en) Expandable vascular implant
DE20314392U1 (en) Flexible stent, for insertion into blood vessels and the like, has projecting bent anchors at the ends of the stent, in a structure with length stability at sites near the heart and in branch vessels
EP1306063A1 (en) Stent

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20051217

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): DE ES FR GB IT

RIN1 Information on inventor provided before grant (corrected)

Inventor name: BRAUN, MICHAEL

Inventor name: MUELLER, HARDY

Inventor name: LESMEISTER, RAINER

Inventor name: GEIS, JOHN

Inventor name: KAUFMANN, RALF

DAX Request for extension of the european patent (deleted)
RBV Designated contracting states (corrected)

Designated state(s): DE ES FR GB IT

17Q First examination report despatched

Effective date: 20080211

REG Reference to a national code

Ref country code: DE

Ref legal event code: R079

Ref document number: 502004014817

Country of ref document: DE

Free format text: PREVIOUS MAIN CLASS: A61F0002060000

Ipc: A61F0002070000

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

RIC1 Information provided on ipc code assigned before grant

Ipc: A61F 2/07 20130101AFI20140905BHEP

INTG Intention to grant announced

Effective date: 20140925

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): DE ES FR GB IT

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

Free format text: NOT ENGLISH

REG Reference to a national code

Ref country code: DE

Ref legal event code: R096

Ref document number: 502004014817

Country of ref document: DE

Effective date: 20150226

REG Reference to a national code

Ref country code: ES

Ref legal event code: FG2A

Ref document number: 2532371

Country of ref document: ES

Kind code of ref document: T3

Effective date: 20150326

REG Reference to a national code

Ref country code: DE

Ref legal event code: R097

Ref document number: 502004014817

Country of ref document: DE

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

26N No opposition filed

Effective date: 20151022

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 13

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 14

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 15

P01 Opt-out of the competence of the unified patent court (upc) registered

Effective date: 20230526

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: IT

Payment date: 20230825

Year of fee payment: 20

Ref country code: GB

Payment date: 20230824

Year of fee payment: 20

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: FR

Payment date: 20230822

Year of fee payment: 20

Ref country code: DE

Payment date: 20230926

Year of fee payment: 20

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: ES

Payment date: 20231027

Year of fee payment: 20